Quality Engineer

Our client is a well established medical devices company with a strong product portfolio.

• Work with cross-functional teams to ensure implementation and/or maintenance of QMS that are appropriate for Medical Devices / Life Sciences Manufacturing / Medical Devices
• Distribution and Services, complies with Commercial/Distribution Quality System such as GDPMD and may also include, but not limited to FDA 21 CFR Part 820, ISO 9001, ISO13485 and other applicable regulatory and statutory requirements.
• Support external audit by certification body and/or regulatory inspections by regulatory agencies e.g. US FDA.
• Coordinate, plan and perform internal audits of processes, facilities and documentation to assure compliance with internal procedures, FDA 21 CFR Part 820, ISO 9001, ISO 13485 and GDPMD regulations and requirements.
• Establish, maintain and update relevant QMS documentation.
• Support in the preparation of generation of metrics and reports to support Quality Management Review.
• Maintain calibration records for all manufacturing tools and equipment.
• LMS administrative role for local procedure and practice.
• Interface with production, process, and test engineering to ensure that products are consistently produced and controlled as per ISO / Part 820 requirements
• Provide QA support in the design, development, sustaining and production of life science / medical device products, facilitating the application of change controls, inspection and testing, risk management activities and quality plan for new product introductions / existing products are in order to sustain product competitiveness while maintaining compliance to domestic and international regulations and standards.
• Conduct customer feedback/complaints and trend review, and drive appropriate continual improvement implementation

What you should do now

Apply to this job ad or send your CV across to me at [email protected] for a confidential discussion.

(Brunel International South East Asia Pte Ltd, Registration Number: 199603098R | Company License Number : 16S8067 | Eve Ng EAP Registration Number R2198025.)