​What you need to know

Matrix Recruitment are seeking to recruit a Senior Design Quality Engineer for our client, based in the Waterford area.

This is a permanent day’s role with benefits.

Your new job

Key duties & responsibilities:

• Represent design quality on NPD and/or device maintenance.

• Ensure project plans comply with FDA, regulatory, & ISO design control requirements.

• Ensure projects meet design, development, technology transfer, validation, and post launch requirements.

• Drive and apply Advanced Quality Planning principles for new product/manufacturing process development activities .

• Manage the documentation of product design control activities.

• Manage product risk management requirements per ISO 14971.

• Review and approve R&D equipment qualification protocols, product/process specifications, analytical method qualifications, development engineering protocols, validation strategies/protocols/reports, clinical trial material protocols & batch records, etc.

• Issue QA Product Release authorizations for new products

• Risk management & complaint data updates

• Support post launch design changes

What are we looking for?

• BS or MS in Engineering or Science.

• 5+ years in medical device or pharmaceutical industry in Quality, R&D, Engineering roles. 

• 5 years in medical device product development.

• Experience in Advanced Product Quality Planning (APQP).

• Familiarity with relevant regulations and standards (i.e., FDA 21 CFR, EU MDD/MDR, ISO-13485, ISO-14971).

• Risk Management.

• Complaint Management.

• Process Validation.

Apply for this job now by emailing your WORD formatted CV to Patricia.

Full detailed job spec available on request.

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position.

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