Total 84 quality assurance job vacancies in D25 Kranji, Woodgrove, Woodlands

Responsibilities

• Provide analysis and dispositions on non-conformance products in accordance to requirements
• Perform inspection and verification (visually or using measuring tools) on product on hold due to quality issues
• Work closely with supervisor & team to monitor project status and closures (team coordination)
• Communicate with customers status of quality projects assigned to his/her area of responsibility
• Prepare regular reports and meet submission deadlines (weekly, monthly)
• Actively participates with internal team projects analysis

Requirements

• Degree in Electronics or Engineering or related field with relevant experience in electronics / semiconductor / or other manufacturing industry
• Entry level candidates are welcome to apply
• Basic knowledge in Microsoft Office (Word, Excel, PowerPoint)
• Team player with good written / verbal communication and interpersonal skills
• Strong sense of urgency with ability to meet deadlines and work independently
• Knowledge in basic manufacturing solving problem tools (8D, FMEA) and statistical tools (SPC) is an advantage.
• Highly motivated to learn new skills / systems / analytical tools used in manufacturing operations

In your role as a Project Manager within the Global Quality (GQ) Department, you will collaborate with the leadership team to oversee various projects. This includes managing communication and implementing change. Your responsibilities encompass the management of multiple intricate projects with the aim of achieving the department’s objectives and goals. This also involves ensuring that resources are allocated in a balanced manner. You will be tasked with ensuring that projects are accurately designed and tracked to forecast results and outcomes. Additionally, you will analyze the progress of projects in terms of root causes, risks, resources, interdependencies, and gaps.

Your key responsibilities include (and not limited to)

• Leading or assisting GQ centric and/or cross-functional projects, collaborating closely with supervisor, SME, functional managers within GQ and partner organizations within Micron and ensuring they progress in line with GQ’s strategic objectives.
• Provide meaningful and timely progress updates to key stakeholders including supervisor, leadership teams, and project teams.
• Building robust relationships with internal stakeholders and consistently meeting their needs and expectations by delivering value.

Skills and Experience:

We are looking for hardworking and highly motivated team member with

• Over 10 years of relevant experience in the role of a Project Manager. Having a growth mindset and possessing project management skills are essential for this role.
• Professional experience in the Semiconductor Industry, specifically in Fab, Assembly and Test manufacturing processes or with NAND, DRAM, SSD or Module products experience.(Required)
• Strong written and verbal communication skills.
• Effective analytical and problem-solving skills.
• Hands-on experience with Tableau or other software for data reporting, management, and visualization.

Education:

• Bachelor’s or Master’s degree or equivalent experience in Electrical, Electronics, Microelectronics, Mechanical Engineering. (required)
• Business Administration/Management, PMP certified. (desired)

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Location: Woodlands

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4500

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

Location: Woodlands

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4500

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

Location: Woodlands

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4500

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

Location: Woodlands

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4500

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

Location: Woodlands

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4500

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

Location: Woodlands (walking distance from MRT)

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4800

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

Location: Woodlands

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4500

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

-Familiar with usage of commonly-used QC testing / measuring instrument

-Organised, methodical, meticulous, pro-active

-Visual Inspection

-Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are upheld and faults rectified

-Responsible, team player, able to communicate and integrate

-Adhoc duties may be assigned

-Perform product inspections, in-process inspections, and Final inspections prior to delivery

-Prepare QC reports

-Communicate in-house and with vendors and products faults, and follow up to ensure rectification

-Familiar with usage of commonly-used QC testing / measuring instrument

-Organised, methodical, meticulous, pro-active

-Visual Inspection

-Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are upheld and faults rectified

-Responsible, team player, able to communicate and integrate

-Adhoc duties may be assigned

-Perform product inspections, in-process inspections, and Final inspections prior to delivery

-Prepare QC reports

-Communicate in-house and with vendors and products faults, and follow up to ensure rectification

• Perform daily inspection task as designated by the supervisor
• Perform in-process inspection and report abnormality/raise NCMR if applicable
• Perform outgoing inspection/out of box audit
• Compile and maintain all quality inspection reports
• Maintain proper 5S in the assigned area daily
• Adhere to Good Manufacturing Practice
• QA inspector is authorized to issue Stop Machine Order and Stop Shipment Order when process/ product out of control.
• QA inspector is authorized to buyoff the product and stamp QC accept/rejec

· Perform incoming, in-process and outgoing quality control activities

· Liaise with customers pertaining product specifications and quality issues

· Update quality standards regularly in order to conform to customer’s requirements

· Perform in-coming, in-process and final QC daily activities

· File and update QC testing records or reports

· Review and verify daily routine QC results

· Liaise with Logistic Coordinator to arrange for outgoing shipment activities

· Report abnormalities to QA Supervisor

· Prepare quality related reports

· Take part in ISO 9001:2015 IQA activities

Any other duties and responsibilities assigned by the Company from time to time

Working Day : 5.5 days

Working Hour : 8.30am to 6pm, 8.30am to 12.30pm

OT available

Location: Woodlands

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4500

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

• Prepare quality reports, perform process audit, develop & implements quality assurance standards, policies, processess & controls.
• Able to liaise & resolve with customers on quality related issues.
• Data compliation, co-ordination and facilitation of all internal and external audits, re-certification of ISO 9001.

Location: Woodlands

Mon to Fri 8.30am to 5.30pm

Industry: Semicon Manufacturing

Salary: $3000-$4500

Job Description

• Manage customer complaints, corrective and preventive action programs.
• Work closely with customers, production and suppliers to meet the quality requirements.
• Responsible for product quality management, implement quality plans, drive quality improvement projects and prepare quality report to identify problem areas and work on problem resolutions
• Interface with and handle customers/vendors on quality issues.
• Issue and closure of CAR for customer (RMA) and Supplier issue – External
• RMA receipt and disposition of RMA in Macola – External.
• Work with QA department and Engineering on customer related issues e.g. RMA

Requirements:

• Degree / Diploma in Engineering (Electrical Engineering, Mechanical Engineering, etc).
• Knowledge of CMM, profile projector, and measuring equipments.

Please submit your updated resume in MS format by using the APPLY NOW BUTTON.

Alternatively, you may also email your resume to us at [email protected]

Emily Fong

Senior Talent Specialist

Atomrecruit Pte. Ltd. | MOM EA License No.: 15C7443

EA Personnel Reg No.: R1768368

Quality/System Manager (Location: Batam)

Responsibilities

• Act as the Quality Management Representative of the company.

• Ensure effectiveness and compliance to ISO/IATF/QMS and various regulatory requirements as needed.

• Lead site quality team to drive operation and product quality improvements via data driven metrics.

• Oversee and support supplier quality, SCAR, product inspection, equipment calibration, CAPA, complaint investigation, change control, LMS training, and NPI activities.

• Chair quality management reviews and manage Internal & External audits.

• Support global quality system process integration, harmonization, and simplification. Managing local implementation and changes.

• Escalate and manage any significant events such as safety, product shipping holds due to quality, regulatory, or any compliance issue.

• Lead or support identified special projects and key initiatives as needed.

• Work cross-functionally to achieve Batam/Singapore site objectives.

Requirements

• Min. Degree in Quality Assurance, Manufacturing or equivalent.

• Min. 3 years of experience in Quality Management Systems in the plastic injection moulding or medical device industry for IATF16949, ISO9001, ISO14001 and ISO13485.

• Knowledge of regulatory requirements and standards relevant to manufacturing such as ISO45001/OHSAS18001 and ISO14001

• Strong customer focus with complaint investigation, significant event reporting and CAPA skills.

• Internal Auditor certification.

• Strong data analysis skills and proficiency in electronic data management systems.

• Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.

• Ability to work independently and collaborate effectively with cross-functional teams.

• Location: Batam, Indonesia.

• Prepare quality reports, perform process audit, develop & implements quality assurance standards, policies, processess & controls.
• Able to liaise & resolve with customers on quality related issues.
• Data compliation, co-ordination and facilitation of all internal and external audits, re-certification of ISO 9001.

· Coordinate, maintain and improve customer-oriented quality system

· Manage and track customer KPIs

· Support and participate on PFMEA

· Develop Inspection Plan for new products

· Lead in solving quality issues and technical problems

· Manage customer claims and 8D reports

· Monitor and evaluate performance of quality leaders and inspectors

Requirements:

· Diploma/Degree in Engineering or related field

· At least 2 years hands on quality experience in a mid-size molding company

· Good problem solving and good communication skills

· TS16949 experience will be advantageous

· Hired permanently as an employee in Singapore and willing to work in Mexico with expatriate package

We invite interested and qualified candidates to send in your updated resume (MS Word Format), stating your reasons for leaving each employment, your current and expected salary to [email protected]. Please indicate the position you are applying in your email subject. Your interest will be treated with strict confidentiality,

We regret to inform that only shortlisted candidates will be notified

EA License: 90C3627

EA Reg No: R1108020

Understanding and interpreting engineering drawings (mechanical) for the quality inspection requirements which includes basic geometric dimension and tolerance (GD&T).

• Able to use various types of measuring equipment including CMM like caliper, micrometers , pin gauges & Thread gauges.
• Hands on knowledge of CMM ( Zeiss ), capable in CMM programming is a plus.
• Ensure in-process quality meets the specification and requirement stipulated in the work instructions or procedure
• Require to perform incoming, in-process inspection &, outgoing inspection using CMM. Maintenance of CMM and Inspection Room.
• Perform inspection of parts as specified including cosmetic appearance.
• Perform calibration and recording for Measuring Instruments.
• Capable of preparing Inspection Report. Familiar with Microsoft office software.
• To organize and assign the inspection jobs to QC inspectors according to delivery priority
• To instruct and advise the QC inspectors the best quality inspection methods and measuring equipment used
• Conduct root cause analysis on rejects and work with programmers, process planners and production on corrective actions.
• Ensure timely resolution of quality issues, corrective actions and preventive actions and all quality rejects are traceable to the person who made the rejects
• Prepare and maintain inspection and test plans/reports for the products and projects according to customers’ requirements and sign off quality reports.
• To conduct daily/weekly QC meetings on quality issues and delivery commitments
• Attend production/project meetings and present delivery commitment and progress status reporting
• Prepare and update quality performance charts and records
• Collect, organise and review quality records in accordance with QMS procedures, customers’ requirements and company's quality management systems and standards

Summary of Role

We are looking for a Technology Quality Engineer to join our team as part of the Global Quality team. The successful candidate will work with the TRB GPO (Global Process Owner) Lead to strategize, develop, implement, monitor, and improve Technology Development & Process Transfer related business process across the organization.

Your Job:

• Accountable for effective execution of the TRB (Technology Review Board) business process at our fabrication (Fab) sites to enable flawless execution on technology development and process transfers.
• Work with TRB Quorum and stakeholders which includes the project team, technical leads, subject matter experts (SMEs), management for technology development and process transfers.
• Validate the technology development and process transfer deliverables against predefined criteria.
• Active engagement with the Fab(s) project team(s) to utilize quality methods and best practices to enhance the overall quality/scope, speed/schedule and cost of technology development/transfer projects and ensure flawless execution through risk-based thinking.
• Proactively work with peers, SMEs, stakeholders and drive risk-based thinking and agreement on continual improvement plans.
• Collaborate with Global Process Owner (GPO) and cross-functional teams to ensure alignment of quality assurance initiatives with overall business objectives, meet compliance requirements and drive towards TRB process excellence.
• Monitor and analyze TRB KPI data to identify trends and opportunities for improvement, and work with business functions to implement corrective actions.
• Develop and deliver training programs to build a culture of quality and continuous improvement across the organization.
• Collaborate and communicate process changes to stakeholders and leadership.
• Represent as interface to global TRB process at local Fab certification audits

Other Responsibilities:

• Perform all activities in a safe and responsible manner and support all Environmental, Health, Safety & Security requirements and programs

Required Qualifications:

• Bachelor’s Degree in Engineering or Science; Masters/PhD
• 5-8 years of work experience in or across semiconductor process technology, R&D and/or Process Transfer Projects, Module Engineering, Design Enablement, Device Engineering, Reliability, or related domains
• Fast learner, strong analytical and problem-solving skills, with the ability to analyze data and identify trends and opportunities for improvement.
• Excellent communication and interpersonal skills, with the ability to build strong relationships with business functions and stakeholders.
• Self-starter with the ability to work independently and as part of a team.
• Language Fluency – English (Written & Verbal)

Preferred qualifications:

• Hands on experience on problem solving/troubleshooting skills
• Working knowledge of ISO9001:2015/IATF16949
• Certified IATF/ISO/VDA Auditor is a plus
• SAP-QM working experience is a plus
• Work experience with multi-national and cross functional environments
• Possess the right attitude to get results with a Growth Mindset

ASM is a leading global supplier of products, services, and materials for semiconductor processing. For more than half a century, innovation has been at the core of everything we do. Our smart, ambitious people are dedicated to creating cutting-edge solutions for the world’s leading semiconductor providers. Every day we push the development of next-generation computer-chip technology, always staying a few steps ahead of what’s next.

The talented, enthusiastic people at ASM are just like you: dedicated to improving people’s lives and unlocking new potential. With our collaborative approach to R&D, we advance key semiconductor technologies and platforms like ALD, epitaxy, PEALD, PECVD, and vertical furnaces. And we have recently entered the promising high-growth market: silicon carbide epitaxy. Year after year, our innovations help to make chips smaller, faster, and more powerful. In fact, you will find our technology in every aspect of modern life: in AI, medical equipment, 5G, smartphones, autonomous driving, and more.

Responsibilities

• Attend daily meeting for quality notification disposition
• Update and Maintain Quality Notification in SAP
• Perform System transaction and maintain physical parts at quarantine location
• Perform material purge and inspection.
• Work cross functional with internal and external team
• Support in First Article Inspection activities

Requirements

• Candidate must possess minimum a Diploma in Engineering
• Minimum 2 years of quality or manufacturing environment
• Proficient in Microsoft Office and SAP or ERP system
• Able to interpret mechanical 2D drawings and technical documents
• Strong communication skills to liaise with both internal customers and external suppliers
• Team oriented and professional philosophy
• Able to perform over time as required by production needs
• Ability to handle up to 5kg of parts during inspection process

At ASM we are committed to supporting our people, enabling them to develop their talents and perform at their best. We actively promote an inclusive and diverse culture that fosters trust and transparency. Our people are our power, and we value the differences between everyone because it is what make us better as a team. By embracing a wide range of perspectives, we enable a culture of continuous exploration and adoption of new ideas. At every step, we know that it is our valued people who enable us to deliver excellent products and service to our clients – and to make a meaningful difference in society.

So join us on our journey and unleash the power of an open mind. Discover how you can be part of our exciting future and apply today! To learn more about ASM, find us at asm.com and on LinkedIn, Facebook, Instagram and YouTube.

About the job

Venture, a public listed company in SGX, is a leading global provider of technology services, products and solutions with established capabilities spanning marketing research, design, research and development. Over the years, Venture has built know-how and intellectual property with expertise in several technology domains. These include life science & genomics, molecular diagnostics, medical devices and equipment, healthcare and wellness technology, lifestyle consumer technology, health improvement products, instrumentation, test and measurement technology, networking and communications, fintech, as well as computing, printing and imaging technology.

Headquartered in Singapore, the Group comprises over 30 companies with global clusters in Southeast Asia, Northeast Asia, America and Europe, and employs over 12,000 people globally.

At Venture, our people are our most valuable asset. We are committed to unifying culture, encouraging innovation, and harnessing the collective strengths and synergies of our human capital to deliver compelling differentiation, advancing Venture’s position as a leading global provider of technology solutions, products and services.

We’re looking to add a Quality Engineer (QMS) in Singapore. The position is based in our Univac Site at Woodlands.

As a Quality Engineer (QMS), you will:

Support the Quality Manager to establish & maintain an effective and best-in-class quality management system & processes in compliance to 21CFR Part 820 QSR, ISO 13485 & ISO 9001 Quality Management System standards, and meeting customers as well as relevant statutory & medical device regulatory requirements.

The key roles and responsibilities are as below:

• Establish, implement, and maintain quality systems in accordance with ISO standards such as ISO 13485, ISO 9001, ISO 14001, and FDA 21 CFR Part 820.
• Develop and manage internal audits and audit schedules; lead a team of auditors to ensure compliance with FDA 21 CFR Part 820 and ISO 13485.
• Promote continuous improvement in all aspects of quality matters.
• Optimize site processes to ensure high performance.
• Oversee document control functions.
• Manage operational efficiency through proactive oversight of the CAPA process.
• Initiate programs to standardize training and increase efficiency.
• Manage external audits conducted by certification bodies, regulatory agencies, or customers.
• Prepare executive presentations for management review.
• Perform any other tasks as assigned.

What skills and experiences are we looking for?

• Diploma and/or Degree in any technical disciplines with at least 3 years of QA/QC working experience in a medical related industry.
• Familiar with the Quality Management Systems requirements such as ISO9001, ISO13485, and 21CFR Part 820 QSR preferred.
• Knowledge in IATF16949 will be an advantage.
• Excellent analytical, presentation, written and verbal communication abilities.

If you embody the spirit of excellence, passion for discovery, innovation and enterprise, and the desire to make a difference in the world of technology and electronics, come join the Venture team!

Be Part of the Venture Family.

---- Communication will be extended to candidates who have successfully advanced in the selection process ----

Quality/System Manager (Location: Batam)

Responsibilities

• Act as the Quality Management Representative of the company.

• Ensure effectiveness and compliance to ISO/IATF/QMS and various regulatory requirements as needed.

• Lead site quality team to drive operation and product quality improvements via data driven metrics.

• Oversee and support supplier quality, SCAR, product inspection, equipment calibration, CAPA, complaint investigation, change control, LMS training, and NPI activities.

• Chair quality management reviews and manage Internal & External audits.

• Support global quality system process integration, harmonization, and simplification. Managing local implementation and changes.

• Escalate and manage any significant events such as safety, product shipping holds due to quality, regulatory, or any compliance issue.

• Lead or support identified special projects and key initiatives as needed.

• Work cross-functionally to achieve Batam/Singapore site objectives.

Requirements

• Min. Degree in Quality Assurance, Manufacturing or equivalent.

• Min. 5 years of experience in Quality Management Systems in the plastic injection moulding or medical device industry for IATF16949, ISO9001, ISO14001 and ISO13485.

• Knowledge of regulatory requirements and standards relevant to manufacturing such as ISO45001/OHSAS18001 and ISO14001

• Strong customer focus with complaint investigation, significant event reporting and CAPA skills.

• Internal Auditor certification.

• Strong data analysis skills and proficiency in electronic data management systems.

• Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.

• Ability to work independently and collaborate effectively with cross-functional teams.

• Location: Batam, Indonesia.

Responsibilities :

Supplier Quality:

1. Ensure supplier quality programs are in line with customers' requirements for manufacturing, packaging and operational processes.
2. Liaise with suppliers CQE on quality, reports and requirements related issues.
3. Maintain and publish supplier quality data for review with stakeholders on regular basis.
4. Liaise with suppliers for quality discrepancy and follow up the improvement actions from suppliers, and monitoring of incoming SPC.
5. Follow up return-to-vendor material issues and claims together with Purchasing.
6. Work with supply chain to drive Cost-of-Poor-Quality improvements and initiatives: Appraisal, Internal and External Cost.
7. To be lead for supplier quality audits.
8. Work with functional team to define inspection criteria to ensure supplier process capability is effective to meet product requirements.
9. Establish incoming material sampling and inspection plan per customers' requirements.
10. Review the CofA/CofC for incoming material, provide analysis of incoming quality.
11. Work in house and with external lab and/or RM Suppliers to ensure statutory, regulatory and products cleanliness requirements are taken care of and follow-up.
12. Prepare material RoHS, Halogen, REACH, CMRT, Prop65, etc, compliance submissions as needed.
13. Develop, expand and maintain in-house laboratory facility/equipment.
14. Oversee the calibration requirements of measuring and test equipment.
15. Work with QC and technical team to establish the laboratory regime.
16. To carry out the project management or ad-hoc projects as assigned.
17. Ensure compliance to QMS, EHS and L&E procedures in the department.