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Quality Engineer, APAC | Medical Devices

Job details

Location: Singapore
Job Type: Permanent
Discipline:
Reference: HLS/EP/QEAPACMD/160119C
Posted: 8 months ago
Consultant: Ewen Poh
Consultant Email: email Ewen
Consultant Phone: +65 6950 0365

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.

This job has expired!