Senior Quality Engineer

Job Summary

We are seeking a proactive and detail-oriented Quality Compliance Engineer to join our Quality Assurance team for a 12 month contact. This role is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, including ISO 13485:2016 and the fully implemented EU MDR.

Your responsibilities will include completion of end-to-end validation lifecycle (IQ/OQ/PQ), performing rigorous risk assessments (pFMEAs), and supporting the change control process to maintain product integrity.

In addition, you will be a primary Quality Liaison for the production floor, supporting and driving root cause investigations and ensuring that manufacturing processes are stable, compliant, and ready for regulatory inspection.

Key Responsibilities:

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Submit your application today and join our talented team at Hollister.