Job Title
Product Quality Assurance Specialist
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About the Role
This position plays a pivotal role in ensuring that new product designs and manufacturing processes adhere to safety and efficacy standards.
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Main Responsibilities
* Represent quality interests on project teams and lead quality engineering tasks.
* Manage risk throughout the lifecycle of new product development projects.
* Verify design control compliance requirements for NPD projects and all design elements.
* Implement corrective actions as necessary.
* Support biocompatibility testing assessments according to ISO10993 and company procedures.
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Requirements
* Bachelor's degree or higher in Engineering, Technical, or Science field.
* A minimum of 5 years' experience in medical devices or pharmaceuticals is desirable.
* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971, and CMDR.