Senior Design Quality Assurance Specialist
7 days ago
About the Role
">This position is responsible for providing technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products, and modifying existing designs.
">Key Responsibilities Include:
">- Assure compliance to applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review, and changes to controlled documents.">
- Provide design control, risk management, and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements, and complaint investigations.">
- Responsible for ensuring Cerenovus Design Control and Risk Management activities comply with requirements of the Cerenovus Design Control and Risk Management processes.">
Requirements
">The successful candidate will have a degree in a technical field and at least 5 years' experience in the medical device industry or IVD/pharmaceutical sector.
">Demonstrated knowledge of design control, sterilization, and Quality Assurance processes is essential.
">A working knowledge of 21 CFR 820, ISO13485, and other foreign medical device quality system requirements is also required.
">Ability to handle multiple projects simultaneously, discern major quality issues, and work well under deadlines and pressure are essential skills.
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