DePuy Synthes Companies of Johnson & Johnson is seeking a Quality Systems Compliance Manager, located in Palm Beach Gardens, FLA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Prime responsibility is to assess and monitor the status of FDA (including QSReg), MDD, and ISO compliance. This is primarily accomplished by directing routine and special request internal compliance audits whose outcomes are documented and reported to responsible company management. Another prime responsibility is to serve as primary or alternate liaison to FDA and/or Notified Body officials during audits of the site.
POSITION DUTIES & RESPONSIBILITIES:
• Direct and/or 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.Qualifications
• Minimum of 8 years quality/compliance experience in the medical device and/or pharmaceutical/highly regulated Healthcare 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 Healthcare 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.
• 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.
United States-Florida-Palm Beach GardensOrganization
Depuy Orthopaedics. Inc. (6029)Job Function