Quality Engineer, APAC | Medical Devices

Job description

Our client is a global leader in cardio devices and critical care products.

Responsibilities:

• 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.

Experiences:

• 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 charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.