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Senior / Quality Assurance Engineer - Incoming
3 weeks ago
**PURPOSE OF JOB
Responsible for establishes and implements Incoming material inspection system, sampling plan, handling and trending of non
- conformance material and supplier corrective action implementation and effectiveness. Lead and provide training to the incoming inspectors.
In the packaging (Boxing) role, responsible to assure finished goods are labelled and packed correctly and complies to packaging procedures. Work orders are inspected and released per Quality Assurance Specifications. Lead and equip the inspectors with the right skills to inspect and release products.
**JOB FUNCTION
1. Provide support in the implementation and maintenance of IQA & Boxing quality system in accordance with international standards (such as ISO 13485, etc) and Quality System Requirements (QSR) of various agencies such as US FDA and other regulatory bodies including effectiveness review of system for continuous improvement.
2. Lead supplier audit program and participate in internal audit to ensure manufacturing is consistence with documented procedures and that the implementation of the quality system requirements is effective.
3. Provide support in root cause investigation and failure analysis on the customer/field complaints and production issues, especially on the assembly & automation process related quality issues.
4. Provide support on product / process qualifications by ensuring quality requirements are fulfilled.
5. Support key initiatives such as reduction in Lot Rejection Rate, Non-Conformance Report, and inspection turn-around time, etc. Play an active role in the Supplier Management Team.
6. Responsible for the maintenance of the IQA & Boxing Quality specifications, provide training to relevant personnel, when necessary.
7. Review non-conformance materials/components and work orders in a timely manner and make recommendations for their disposition to support the sales fulfilment process to ensure predictable product flow.
8. Provide support on supplier management program including qualification and assessment of new suppliers as well as supplier visit.
9. Provide QE supports in the finished goods inspection and released.
10. Maintain a safe and healthy work environment by complying with all related safety regulations in the company.
11. Ensure existing or potential hazard areas are identified and corrected to prevent injury to employees or damage to property.
12. Any other duties assigned by the immediate superior.
**INTERACTION**
- Internal communication with all levels of plant operation personnel.
- External liaison with suppliers on part quality.
**JOB SPECIFICATIONS**
- For Degree
- 3 years of relevant experience in Engineering / Science or quality related field.
- For Diploma / Advance Diploma
- 5 years of relevant experience in Engineering / Science or quality related field.
- For senior position
- 3 years of supervisory experience is required.
- Experienced in Supplier Quality Management and Quality management System.
- Good communication and interpersonal skills, ability to articulate ideas clearly and concisely to all levels of people.
- Experience in cGMP, ISO 13485 and FDA QSR 21 CFR 820 quality system are essential and MDSAP requirements is an added advantage.
- Knowledge in plastic / polymer technology.
- Ability to contribute in a team environment, action oriented, strong drive for results and good influencing skills.
