Manufacturing Engineer Role Overview
Job Summary:
We are seeking an experienced Manufacturing Engineer to drive compliance improvements and process validation initiatives. This role involves partnering with manufacturing teams to identify and remediate compliance gaps.
* Partner with manufacturing teams to identify and remediate compliance gaps.
* Support manufacturing process validation activities (IQ/OQ/PQ).
* Update quality system documentation and technical files to ensure audit readiness.
* Drive closure of CAPAs and NCRs with effective corrective actions.
* Provide clear and concise technical writing for quality and manufacturing procedures.
Key Responsibilities:
This position requires strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management. The ideal candidate should have a Bachelor's degree in Engineering or Quality-related discipline and 2–5 years of experience in medical device manufacturing, quality, or remediation projects.
* Bachelor's degree in Engineering or Quality-related discipline.
* 2–5 years of experience in medical device manufacturing, quality, or remediation projects.
* Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
* Proven technical writing and documentation skills.
* Familiarity with industry quality standards.
Benefits of this Opportunity:
* Collaborative work environment.
* Opportunity to contribute to the success of our client.