Job Opportunity: Quality Engineer
This role plays a vital part in ensuring site-wide remediation programs align with FDA 483 guidelines.
About the Position:
* Collaborate with manufacturing process owners to identify and rectify compliance gaps.
* Support the validation of manufacturing processes (IQ/OQ/PQ).
* Update quality system documentation and technical files for audit readiness.
* Promote the effective closure of CAPAs and NCRs through corrective actions.
* Provide clear and concise technical writing for quality and manufacturing procedures.
Critical Skills Required: Process Validation, CAPA/NCR Management, Technical Writing, Regulatory Compliance, ISO13485
Essential Qualifications:
* Proven experience in quality engineering or a related field.
* Strong understanding of regulatory compliance requirements.
* Excellent communication and problem-solving skills.
* Able to work collaboratively in a team environment.