Our client is a global leader in cardio devices and critical care products.
- Distribution Centre Quality Management (20%)
- Implement and maintain Label Management Process and Over-Labeling Process at 3PL, to eliminate Quality Risk related to Local Over-Labeling Activities.
- Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, Over-Labeled Products, and Returned Products
- Implement and track Quality Hold in 3PL
- Manage the Supplier Quality metrics such Supplier Corrective Action Requests (SCAR), Corrective Action and Preventive Action (CAPA)
- Initiate and follow-up Supplier Corrective Actions (SCAR) in partnership with Manufacturing Engineering to ensure complete and effective root cause analysis and corrective action implementation.
- Provide suggestions to improve 3PL Quality Management System to meet Quality Agreement requirements
- Quality Engineering (50%)
- Oversight the overall validation (IQ/OQ/PQ) activities. Write and execute validations protocol for Final Packaging and Labelling.
- Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, nonconformance’s, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
- Develop and Maintain inspection plan and procedures for incoming materials and Finished Goods
- Develop, update, and maintain technical content of risk management files, FMEA, Master Validation Plan, Quality Control Plan, etc.
- Provide quality training (technical related).
- Supplier Management (30%)
- Supplier Qualification; Implement the new supplier qualification through supplier risk assessment, onsite qualification audit, FAI, etc.
- Participant and Support in Supplier Audit Program
- Work with cross functional teams to resolve supplier quality issues in a timely and systematic methodology.
- Bachelor's Degree or equivalent related field, 3 years previous related experience required and
- 3 year of experience in a quality and/or manufacturing environment in the medical device industry preferred
- Sound knowledge of ISO 13485 for medical devices
- Sound knowledge of FDA Quality System Regulations; 21 CFR Part 820 (Part 210 & 211) knowledge/experience is a plus
- Good computer skills in MS Office Suite
- Good problem-solving and critical thinking skills
- Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Basic understanding of statistical techniques
- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Solid problem-solving, organizational, analytical and critical thinking skills
- Solid understanding of processes and equipment used in assigned work
- Knowledge of and adherence to Quality systems
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
- Ability to build productive internal/external working relationships
Please contact Ewen Poh at +65 6435 5616 or firstname.lastname@example.org for a confidential discussion
EA License no: 16S8066 | Registration no: R1550486
Only successful candidates will be notified.