Compliance and Process Expert
Job Description
Overview: We are seeking a skilled expert to support a critical site-wide remediation program following an FDA observation.
This role offers a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to drive compliance improvements and process validation initiatives.
Responsibilities:
* Partner with manufacturing process owners 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.
* Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.
Qualifications:
* 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 21 CFR Part 820 and ISO 13485 quality standards.
* Excellent problem-solving skills with the ability to take a problem statement through to a compliant solution.
* Must be available to work onsite.