Our client is from Medical Manufacturing industry. They are looking for a QA Engineer to assist their team for the next phase of their business. They are located in West.
Duties:
- Identify and address quality requirements, supporting the design control process and maintaining design history files discreetly.
- Offer QA-related support for new product development and product enhancement, while maintaining confidentiality.
- Generate or review validation/verification documents and provide discreet support for Quality investigations related to validation/verification reject inquiries.
- Create or update Quality documents, such as Quality Plans, Quality Inspection documents, and Lot Release Documents during the development phase discreetly.
- Coordinate the revision of incoming material specifications and First Article Inspection (FAI) activities with the Supplier Management Group during development.
- Lead and conduct Product Risk Management assessments for current products and new/enhanced products discreetly.
- Maintain Risk Management Files and Risk Management Plans in accordance with EN ISO 14971 while maintaining confidentiality.
- Oversee tasks like Design History Record (DHR) reviews, returned device decontamination, and returned device investigations discreetly.
- Take responsibility for returning 3rd party complaint products to manufacturers while ensuring confidentiality.
- Participate in internal audits, external audits, and Quality Assurance projects as needed while maintaining confidentiality.
Requirements:
- Min Degree in Biomedical Engineering or any relevant field.
- Min 2 years' of working experience in relevant industry.
- Experience in environmental control will be an advantage.
Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv. We regret that only shortlisted candidate will be notified.
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