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East Riding of Yorkshire
- experienced in Electro-mechanical
- Desired - new product development / design & development
About Our Client
You may be involved in the following activities as part of your day to day responsibilities:
- Ensure compliance of design control and design change activities through the review and acceptance of design activities independently of the New Product Development (NPD) design team.
- Ensure that Design History Files and other associated quality documentation are complete and compliant by means of review and approval.
- Work with New Product Delivery (NPD) teams to ensure verification and validation outputs meet design inputs through the creation-review-execution of test cases and participation in product risk analyses and change reviews.
- Provide support to Operations and Downstream QA teams to ensure successful transfer of the design and design controls to manufacturing, in accordance with all applicable regulations.
- Assist in the adoption of test methods, equipment acquisition for product testing, validations/qualifications, statistical analysis of data for significance and other requirements through review and approval of protocols and reports.
- Participate in the creation and approval of complete, unambiguous, and measurable design outputs.
- Review and approve development specifications, including those for raw materials, intermediate products and finished products.
- Maintain currency of knowledge required to carry out the essential duties and responsibilities effectively.
- To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
- To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
The Successful Applicant
- Holds a professional scientific qualification e.g. B.Sc. Hons Electro-Mechanical / Electrical/ Manufacturing Engineering or equivalent based degree with a minimum of 2:2 classification result and above.
- Or a HNC or equivalent qualification with a substantial amount of experience in a similar Quality, Compliance or Regulatory related role in relation to product development within a Medical Devices and / or Medicinal Product / Electro-mechanical / Healthcare / Pharmaceutical environment.
What's on Offer
Competitive salary and benefits