Quality Systems & Compliance Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Quality

Customer/Commercial Quality

Professional

Markham, Ontario, Canada

Johnson & Johnson is currently seeking a Quality Systems & Compliance Specialist to join our Med Tech Surgery Commercial Quality team located in Markham, ON, Canada. This is an 18-month fixed-term role with 3 days in office per week.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer.

Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at

• Oversees and supports Markham SDC’s daily issues or inquiries
• Supports and executes key strategies and related measures/metrics necessary to deliver on MT Commercial Quality’s and Deliver Operations’ compliance and culture/credo goals.
• Ensure quality systems are well integrated into the business in critical areas for control including but not limited to: product receipt and inspections, storage and handling, supplier management, non-conformance management, change management, document/records management, training to ensure compliance with J&J Standards and regulatory requirements.
• Supports regulatory inspections, JJRC and internal/external audits via preparation and implements corrective actions as appropriate
• Supports Commercial Quality Segment teams for their external audits impacting storage and handling of products at the Markham SDC
• Serves as one of the primary contacts between Global Manufacturing sites and J&J Med Tech Canada for product Hold process. Leads holds/stop shipments to ensure products are investigated, segregated and on ERP system-hold. Connects with appropriate stakeholders to ensure holds/stop shipments are executed in timely manner. Leads follow-ups with Global Manufacturing Sites to provide product disposition and closure status.
• Supports as Master Data Governance Functional Data Steward on behalf of MT Surgery Commercial Quality
• Serves as backup contact for Supplier selection/qualification/audits/remediation activities for MT Surgery Commercial Quality. Activities include but not limited to Supplier selection, on-going monitoring, disengagement, supplier qualification, supports review of quality agreements, collaborates appropriate internal/external functional groups to select, qualify, disengage suppliers as necessitated while implementing risk-based approach, ensures J&J Policies / Standards are met.
• Supports quality deliverables on projects, acquisitions and divestitures and ensures project timelines are met.
• Conducts gap assessments and develop local implementation against J&J standards
• Advises management on escalation of issues as per J&J Standards as directed by Business Unit
• Serves as back-up for MT Commercial Quality Manager and MT Commercial Quality team members for the SDC
• Other…