QUALITY ASSURANCE ENGINEER (Validation & Verification)

Job Outline:

Responsible for reviewing and maintaining validation & verification activities to ensure manufacturing processes, equipment, software systems, test methods, and facilities comply with applicable regulatory requirements, Quality Management System (QMS) standards, and applicable global medical device regulations.

Participate in new project introduction and project transfer qualification activities, such as lead on qualification and validation strategies.

Coordinate validation activities for software used in production, quality, and manufacturing processes where appropriate.

Ensure validation and verification documentation is accurate and meet applicable regulatory expectations.

Perform periodic review and revalidation activities as required.

Coordinate and support investigations involving nonconformances, customer complaints and/or audit findings related to validation. Follow-up on the corrective and improvement actions as required.

Support measurement system verification activities, including Gauge R&R and measurement system analysis (MSA).

Provide training to quality technicians, inspectors or relevant personnel on validation requirements and best practices when necessary.

Other responsibilities are subject to the arrangement of the immediate superior/management.

Authority:

Make the decision on validation & verification acceptance criteria.

To stop production or shipment when nonconformance is found due to not meeting validation and/or verification requirements.

Academic Qualification:

Possess at least Bachelor's Degree in Science (Material / Physics / Chemistry/ Mechanical/ Biomedical), Engineering or other related technical disciplines.

Experience / Skill Required:

Required skill(s): Validation & Verification, Minitab, 8D report writing.

Understanding of ISO 13485 requirements and validation lifecycle activities.

Knowledge in equipment qualification (IQ/OQ/PQ), process validation, change control, CAPA, and nonconformance management.

Other knowledge in QC core tools, ISO 9001, ISO 14001, ISO 13485 and IATF16949 Quality Management system, PPAP, FAI, CPK, MSA, FMEA and control plan is essential.

At least 2-3 year(s) of working experience in Quality Assurance function, validation and/or verification activities within a regulated manufacturing environment.

Able to comprehend and interpret part drawings and technical instructions.

Self-motivated and self-discipline.

Proficiency communication skills and able to work independently and as a team player as well as interact with people at all levels.