Quality Lead/ Supervisor (QAQC)

Location: Penjuru Place (shuttle bus provided)

Monday - Friday 8am - 5.30pm

The Quality QAQC Supervisor is responsible for ensuring timely and effective implementation of the company's policies, procedures, and standards involved in assuring the quality of manufactured products and customer satisfaction, as well as for conducting quality control activities. The Quality Supervisor strives to ensure the facility adheres to quality licenses, standards and certifications.

A successful candidate will collaborate closely with functional areas such as Manufacturing, Procurement, Mfg. Engineering, Sustaining Engineering, Product Lines, R&M and Geozones regularly as well as presenting to internal teams plans and updates.

Job Responsibilities:

• Supervise and lead Quality Assurance and Quality Control personnel.
• Maintain site Quality Management System.
• Update QMS records and maintain all necessary documentation and certificates.
• Responsible for following management of change as processes and procedures are updated as per QMS requirements.
• Perform regular process audits in Manufacturing areas and functional areas, including technical work instructions, processes, procedures, and competence and ensure compliance.
• Generate CARs related to any deficiencies and track them to completion.
• Keep competency records up-to-date.
• Conduct training related to QMS, procedures, WIs, others.
• Actively participate in Contract Reviews.
• Develop customer QCP Plans. Ensure contractual requirements are built into Quality Control plans.
• Actively participate in Pre-Production meetings.
• Coordinate Client visits, and audits and constant communication to demonstrate our commitment and promote the Corporate Quality Management System.
• Drive action trackers to completion, related to customer audits, manufacturing reviews or qualification process.
• Coordinate TPIs per customer QCPs, and per production schedule. Ensure documentation meet requirements.
• Review/release WOs from a Quality point of view.
• CPARs/NCRs/COPQ; monitor performance/trends, data analysis, and evaluate the effectiveness of corrective actions to ensure that the required improvements are sustained. Actively participate in RCA. Monitor/track other Quality KPIs.
• Coordinate with product design engineers and manufacturing engineers the requirements in the quality plans and inspection and test plans to be aligned with their engineering design criteria, production schedules and customer requirements.
• Coordinate quality assurance plans for new PNs/product introductions.
• Review and approval purchased materials/products mill test certificates if it complies with the required company specifications and/or applicable industry standards prior to acceptance and use.
• Ensure quality control inspection and testing activities are performed in accordance with Global MFG QMS, customer QCPs/Inspection matrices, and/or local procedires and work instructions.
• Manage non-conformance process in accordance with Global MFG QMS.
• Identify a minimum of two continuous improvement projects per year to lead and complete with measurable improvement to the business in terms of margin, quality, etc
• Any other delegated responsibilities as instructed by his direct supervisor within the timeframe specified safely and efficiently to meet business requirements, provided the instruction is reasonable and you are capable and deemed competent to fulfil these.

Job Requirements:

• 5 to 8 years of experience with ISO-9001 and API Q1
• Minimum 5 years of experience in QA/QC role in the manufacturing environment
• Excellent written, reading, and oral communication in English
• Computer literate and familiar with Microsoft Office software at a minimum
• Fast learner, results-oriented and independent with strong interpersonal skills
• Possess strong customer service skills, i.e. listening, follow-through, and willingness to help
• Certified Auditor
• Ability to read engineering drawings
• Ability to interpret MTCs (Material Test Certificates) against the Company specifications
• Skilled at data mining (Excel Pivot Tables, other Excel tools)

Job Responsibilities:

• Develop & implement QMS system & take the lead of continuous improvement process & initiatives
• Provide root cause analysis & preventive action plans to resolve non-compliance issues
• Analyze internal & external data to identify areas for improvement & communicate with relevant parties for quality improvements
• Ensure the compliance with ISO 9001 & all relevant standards to both internal company policies & customer standards

Requirements:

• Diploma in Mechatronic, Electronic Engineering or equivalent or
• 3 years Quality experience in Service/Maintenance/Repair industry
• Possess good knowledge of ISO 9001, QA methodologies & tools
• Good communication & interpersonal skills

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Basic Functions:

• Assist in maintaining company’s compliance to quality management system established.
• Responsible in monitoring the calibration and maintenance program.
• Ensure that ISO 13485, In-vitro Diagnostics Directive 98/79/EC, IVDR 2017/746 and 21 CFR Part 820 Quality System Requirement, MDSAP (Medical device Single Audit Program) are properly implemented and maintained at all levels.
• Establish and maintain proper document archiving and control system.

Duties:

• Assist in maintaining company’s compliance to quality management system established.
• Assists in internal and external audits.
• Responsible in handling the corrective and preventive action system and its sub-system (i.e. Nonconforming product and internal audit).
• Ensure that proper document control procedure and system is implemented for Product Specifications, Operation Manuals, Standards, Drawings and all quality related documents.
• Control and compile Production / QC Master Batch Records and ensure that the Quality Records Master List is updated. Together with the Documentation Center, ensure that all documents submitted and/or generated are archived.
• Co-ordinate, review, collate, update and issue all quality-related documents to relevant personnel.
• Prepare necessary documentation (e.g. Certificate of Analysis and Certificates of Origin) to support shipment of products overseas.
• Control and compile Production / QC Master Batch Records and ensure that the Quality Records Master List is updated. Ensure that all documents submitted and/or generated are archived.
• Receive Production / QC Records and all quality related documents and ensure that proper document archiving and control system is implemented.
• Ensure that all documents submitted and/or generated are archived.
• Compile and ensure that the Quality Records Master List is updated.
• Perform other duties as assigned.
• Support the projects of material qualification
• Any other duties as and when assigned.

Minimum qualification Requirements

Ability to:

• Demonstrate the use of all equipment, materials, and techniques relevant to job performance, execute and maintain pertinent validation protocols as required and maintain quality standards.
• Establish quality assurance system and undertake systems / product / process validation

Knowledge of: Various quality control/process control requirements, quality management system and documentation relating to biomedical and /or IVD products. Technical terminology used in the laboratory, assigned scientific techniques and knowledge of QC procedures governing a number or basic laboratory operations.

Education: Basic Science Degree

Experience: No prior working experience is required for Executive position. At least 3 years of relevant working experience for Senior Executive position.