Introduction

What are you going to do

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 equipments
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 e.ng@brunel.net for a confidential discussion.

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

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