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Senior Design Assurance Expert
2 weeks ago
We are seeking a highly skilled Senior Design Assurance Engineer to join our team at Pale Blue Dot Recruitment.
Job Description:The successful candidate will be responsible for ensuring the quality and safety of medical devices through comprehensive design verification and validation testing.
Main Responsibilities:
- Conduct and support comprehensive design verification and validation testing, ensuring test methods are robust and compliant with regulatory standards.
- Drive continuous improvement by leading or supporting CAPA initiatives related to design and test methods.
- Lead or support the design controls process, including participation in design reviews and design change processes.
- Conduct and manage Design Failure Mode and Effects Analysis (dFMEA) and ensure seamless transition to Process FMEA (pFMEA) during the design-to-manufacturing phase.
- Compile technical documentation for regulatory submissions, ensuring compliance with industry standards and regulatory requirements.
To be successful in this role, you will need:
- A Bachelor's degree in Engineering, Scientific, or Technical field (ASQ Certified Quality Engineer (CQE) accepted).
- Minimum of 3+ years of experience in Design Assurance or R&D within the medical device industry.
- Hands-on experience working within an ISO 13485 Quality Management System (QMS) or equivalent regulated environment.
- Strong experience with design controls, design reviews, and design change processes.
Pale Blue Dot Recruitment is a leading recruitment agency specializing in the MedTech industry. We offer a range of services to help clients find the best talent for their business needs.
