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 MedTech, 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. Learn more at jnj.com 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. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Markham, Ontario, Canada Job Description: Johnson & Johnson is currently seeking a Quality Systems & Compliance Specialist to join our MedTech Surgery Commercial Quality team located in Markham, ON, Canada. This is an 18-month fixed-term role with 3 days in office per week. About Surgery 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 https://www.jnj.com/medtech The J&J MedTech Surgery Commercial Quality Canada team is seeking a Quality Systems & Compliance Specialist for an 18-month contract position, reporting to the Quality Systems & Compliance Manager.  This role is responsible for supporting and maintaining Quality Management System (QMS) and ensuring compliance with applicable Health Canada regulations and J&J Corporate Standards. This position has primary responsibility for quality systems and compliance activities at the Markham Shared Distribution Centre (SDC), which stores and distributes products for J&J MedTech, J&J Innovative Medicine and J&J Surgical Vision.  In this capacity, the Specialist will partner closely with DELIVER Operations, MedTech Business Unit Quality teams, Commercial Quality Segment teams across Innovative Medicine, Vision and Shared Services, as well as Supply Chain Planning, Marketing and 3PL Operations and Quality to support quality oversight, compliance activities, and continuous improvement initiatives across the distribution network.

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 MedTech Canada for product Hold