Position duties & responsibilities:
- You'll direct and conduct internal and external audits against QSReg and ISO.
- Lead site specific audit readiness activities.
- Provide audit results to management and coordinate audit CAPA/OBS actions.
- Direct or conduct personnel training on FDA and ISO requirements.
- Review and approve all site and applicable corporate SOPs, WIs, etc.
- Direct and/or conduct investigations into potential quality/compliance concerns. Keep management informed of issues.
- Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements. Monitor external publication sources for issues applicable to DePuy Synthes.
- Provide consulting service to site and corporate personnel.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.
- Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
- Perform all other duties as assigned.
- Minimum of 8 years quality/compliance experience in the medical device and/or pharmaceutical/highly regulated industry.
- Direct contact/interaction experience with the FDA, ISO registrars and other notified bodies is required
- A minimum of 3 years’ experience directly performing audits in the medical device and/or pharmaceutical/ highly regulated industry is required.
- Experience working with Manufacturing, Product Development and Corporate functions is preferred.
- This position will be based in Palm Beach Gardens, FLA and requires up to 15% travel.
- EDUCATIONAL REQUIREMENTS:
- Bachelor degree in science, engineering, quality or other technical field.
- Auditor Certification, such as ASQ CQA, is preferred.
- Documented training in FDA Quality System Regulation (QSReg), ISO 13485 and MHLW Ordinance 169.
Requisition ID: 9564170901