Responsibilities
- Use structured problem-solving techniques to resolve quality issues in product design and manufacturing processes.
- Deliver quality engineering expertise within interdisciplinary teams developing new products, ensuring proper design inputs, testing, and adherence to regulations.
- Assist in risk assessment tasks such as hazard identification and failure mode analysis, aligned with ISO 14971 and internal protocols.
- Create, evaluate, and authorize verification and validation documentation to meet regulatory expectations.
- Build and manage Design History File records, including design inputs, specifications, and outputs.
- Participate in design change management by evaluating impacts on product performance and regulatory compliance.
- Track post-market device performance, identify trends, and assist in implementing corrective and preventive measures.
- Support ongoing quality improvement projects to strengthen product reliability and team efficiency.
Work Arrangement
On-site
Other
- Relocation assistance is available for eligible candidates.
- It is illegal to require or conduct a lie detector test as part of employment; violations carry criminal and civil consequences.
- This position is classified as safety-sensitive, requiring a prohibited substance test in accordance with company policy and legal requirements to promote workplace safety.
