Quality Assurance Engineer
The role entails collaborating with manufacturing and quality teams to strengthen compliance and support process validation initiatives.
* Collaborate with production owners to identify gaps and implement corrective actions to achieve compliance.
* Contribute to equipment and process validation activities (IQ/OQ/PQ).
* Maintain accurate quality system records and technical documentation to ensure audit readiness.
* Lead the closure of CAPAs and NCRs with robust corrective actions.
* Develop clear, concise technical documentation and SOPs for quality and manufacturing processes.
* Work in tandem with cross-functional teams, including Manufacturing, Quality, and Regulatory, to deliver sustainable solutions.
Requirements include a degree in Engineering, Quality, or a related field, 2–5 years of experience in medical device manufacturing, quality engineering, or remediation work, and exceptional technical writing and documentation abilities.