Remediation Specialist Role
A key position has become available for a skilled Remediation Specialist to join our site-wide remediation program following an FDA 483. This is a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to drive compliance improvements and process validation initiatives.
Key Responsibilities:
• Partner with manufacturing process owners to identify and address non-compliance issues.
• Support process validation activities including IQ/OQ/PQ.
• Maintain and 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.
Required Qualifications & Experience:
• Bachelor's degree in Engineering or Quality-related discipline.
• 25 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.
Benefits of this role:
This is an excellent opportunity to make a meaningful contribution to our organization and develop your career as a Remediation Specialist. If you are passionate about ensuring product compliance and improving process efficiency, we would like to hear from you.