(W) Quality Assurance Engineer - Medical Device Manufacturing
10 months ago
Job Summary:
Work Schedule: Monday through Friday, from 8:30 a.m. to 6:00 p.m.
Location: Serangoon North
Monthly Salary Bracket: Up to $5500 (B..
Job Summary:
- Work Schedule: Monday through Friday, from 8:30 a.m. to 6:00 p.m.
- Location: Serangoon North
- Monthly Salary Bracket: Up to $5500 (Base Salary)
Primary Duties:
- Foster interdepartmental collaboration to ensure thorough understanding and compliance with the Quality Management System.
- Lead quality audits to ensure their efficient execution.
- Develop and implement crucial procedures and processes.
- Continuously assess the suitability of the Quality Management System and identify areas for improvement.
- Conduct comprehensive training on ISO13485, ISO14971, and FDA 21 CFR Part 820, with provisions for refresher courses as needed.
- Plan and coordinate external audits, including those conducted by customers, ISO certifications, and regulatory agencies.
- Provide guidance and supervision to team members, ensuring timely and accurate completion of quality initiatives.
- Support plant-wide audit and inspection activities, as well as special projects.
Qualifications:
- Bachelor's Degree in Quality Management or Electronics Engineering.
- Minimum of 3 years of hands-on experience with Quality Management Systems in a manufacturing setting.
- Profound practical knowledge of Quality Management Systems, especially ISO 13485 and FDA 21 CFR Part 820.
- Proficiency in establishing control systems required for ISO13485 & FDA registered facilities.
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Poon Weng Teik (Wilson) | EA Personnel License: R1657737
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