Senior Design Quality Engineer

3 weeks ago

Dublin, Ireland Oxford Global Resources Full time

Are you interested in taking the next step in your career with a global leader in medical devices and healthcare? Are you ready to challenge yourself? Are you an experienced medical device Quality Engineer with a background in packaging design and regulatory compliance? You could be the perfect candidate for this opportunity Don't hesitate, apply today

Job Description

Our client are seeking an experienced Quality Engineer with a background in packaging and design transfer to support an upcoming project remotely in Ireland. The successful candidate will be responsible for defining design requirements and developing manufacturing processes to support new product development projects. They will lead risk management activities to ensure the highest level of product and process quality.

Key Responsibilities

- Develop QA documentation to support product transfer, development process, and regulatory submissions
- Partner with cross-functional project teams to lead product transfer and/or process design and development activities.
- Lead risk management activities for new product transfer and development projects.
- Present risks associated with the product and track the design, documentation, and manufacturing process, to mitigate those issues.
- Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
- Partner with Advanced Operations in the assessment of manufacturing processes for products.
- Develop, review, and approve inspection plans, routers, and product drawings for products.
- Support product design transfers to internal and/or external manufacturing facilities.
- Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.

Key Requirements

- Experience with medical device product development lifecycle, including risk management, usability, and design/process verification and validation.
- Strong knowledge of Packaging Development/Manufacturing process and related standards
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes and Effects Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
- Demonstrated ability to read and interpret CAD drawings.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Bachelor's Degree (Level 8) in a science, engineering or related discipline with MS, CQE, or CRE preferred
- Six Sigma Green or Black belts are preferred
- Minimum of 5 years' relevant experience

Benefits

- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid holidays

Location: Ireland | remote

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