JOB SUMMARY:

The scope of this role is to support the Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore and develop, improves manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Includes the following. Other duties may be assigned.

· Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.

· Design and develop manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.

· Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.

· Improves manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.

· Process qualifications and validations including equipment qualifications and material specifications.

· Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.

· Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.

· Prepares product and process reports by collecting, analysing, and summarizing information and trends.

· Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.

· Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.

· Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.

· Oversee and drive Validation Activities.

· Maintain and comply with ISO13485, GMP and FDA regulations.

SUPERVISORY RESPONSIBILITIES:

N.A.

Education/Experience and Qualifications:

• Availability to travel to sending site for duration of onsite training
• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques.
• Knowledgeable in defining process capabilities and control charting.
• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Working knowledge of standard machine shop equipment is required.

· Proficiency with CAD software is required.

· Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives

• Self-motivated and driver of change and innovation. Must be willing to work in a fast-paced environment with minimum supervision.

Work Environment:

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Controlled Environment (Class 100K cleanroom) and office area.

Our client is a Manufacturing company in the Biomedical industry. Due to their current expansion plan, they are looking for a Production Supervisor to join their Production team, in hopes of developing the current high performing production team. They are located in the North – easily accessible.

Duties

• Assist in overseeing daily production operation to ensure day-to-day operation runs smoothly
• Supervise the production team and responsible for manpower and machines allocation
• Execute and train staffs in production team to ensure they can perform their jobs accordingly
• Maintain and improve molding processes to reduce discrepancies
• Ad hoc duties assigned by superior

Requirement

• At least 2 years of experience in Manufacturing industry
• Diploma in any discipline

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email Address: [email protected]

EA License No: 19C9682
EA Personnel No: R2198636
EA Personnel Name: Oh Puey Xin

Responsibilities

1. Responsible to analyse food safety and quality results and track performance against established goals and assist in periodic reporting of performance.
2. Serve as first point of contact for all customer quality inquiries, aiding in scheduling of audits, providing feedback to both simple and complicated inquiries.
3. Develop, update and implement current Food Safety Management System (BRC), HACCP and Halal Quality Management System (MUIS) in accordance to standards to ensure products produced meet relevant regulations and certification requirements.
4. Ensure production, warehouse and areas where activities affect food safety and quality comply with GMP.
5. Lead and conduct investigation of customer complaints, maintain investigation log and track investigation closure.
6. Issue CPAR to internal and suppliers for all non-conforming products including raw materials, work-in-progress and finished products.
7. Conduct annual mock recall, traceability and mass balance exercise.
8. Support and assist external audits and inspection including 3rd Party, Customer and Regulatory audits and inspections.
9. Develop and conduct appropriate training in all aspects of food quality and safety to ensure compliance to established systems.
10. Responsible for the application of Export Health Certificate and Phytosanitary Certificate.
11. Provide technical advice and support to sales, shipping, maintenance and production department.
12. Responsible to issue and complete customer inquiries, questionnaires, COA, product specifications and declarations.

Requirements

1. Minimum Diploma in Food Science or equivalent.
2. We welcome all to apply. Ideally, candidate should have 1-2 years' experience in the food industry to have shorter learning curve.
3. Basic Computer Knowledge and proficient in Microsoft Office software
4. Able to handle English and Mandarin speaking staff and customers representatives.
5. Be able to work interpedently with a high level of initiative and resourcefulness.
6. Fast learner and able to work under pressure.
7. Good communication and interpersonal skills.
8. Good understanding of Food Safety Management System.

Note:

We are also looking for Clerical Officer to handle admin in QA QC Dept for those who do not meet the QA Executive requirements but wish to undertake admin clerical work in QA QC Dept. You can apply via this ad too.