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 Cutting-edge 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.ComAs 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 FunctionQualityJob Sub FunctionCustomer/Commercial QualityJob CategoryProfessionalAll Job Posting LocationsMarkham, Ontario, CanadaJob DescriptionJohnson & 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 SurgeryFueled 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/medtechKey ResponsibilitiesOversees and supports Markham SDC’s daily issues or inquiriesSupports 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 appropriateSupports Commercial Quality Segment teams for their external audits impacting storage and handling of products at the Markham SDCServes as one of the primary contacts between Global Manufacturing sites and J&J MedTech 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 QualityServes 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 standardsAdvises management on escalation of issues as per J&J Standards as directed by Business UnitServes as back-up for MT Commercial Quality Manager and MT Commercial Quality team members for the SDCOther duties as assignedQualificationsBSc or equivalent in Life Sciences or related field, post graduate program in Quality is an assetMinimum 2 to 4 years of experience working in a regulated setting. Experience required in a device or pharma Quality/Regulatory environmentStrong knowledge of medical device and/or pharma Quality Management SystemsKnowledge of GMP's, GDP's, Quality Systems, Canadian Drug and Medical Device RegulationsExperience across the elements of a quality organization – quality systems (CAPAs, NCs, Change Controls), quality operations and regulatory complianceExperience in supporting inspections (health authority inspections, internal audits,



external audits)Experience with the distribution practices and requirements of regulated products (medical devices and pharmaceuticals).Direct working knowledge of the business environment outside of the Quality organizationAbility to work with ambiguity and in a complex/rapidly changing environment and make the complex straightforward for others to understand.Ability to work with broad scope/different types of products in a fast-paced environmentBig Picture Orientation with Attention to Detail to understand complexities of the businessAbility to work in a matrix environment with multiple stakeholders and prioritiesAbility to apply risk management philosophy to business processes, decisions, and dataSense of urgency, results and performance driven; and works independentlywith minimum supervision.Preferred Skills: Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report WritingSalaryThe anticipated base pay range for this position is :$65,000.00 - $103,500.00Additional Description for Pay TransparencyThe anticipated base pay range for this position is $65,000-$103,500 CADUnder current guidelines, this position is eligible for a discretionary completion bonus.The Company uses AI in its assessment of applicants.This job posting is for an existing positionBenefitsBenefits: https://jnjbenefitsguide.Ca/We have a flexible benefits plan (incl. company paid medical; dental;vision coverage) that gives several options/plans to choose from depending on family needs. Benefits are effective as of the first day of work:Basic life insurance coverageBoth short-term and long-term disability coverageAD&D (Accidental Death & Dismemberment) coverageRRSP (Registered Retirement Savings Plan)- there is a company match of 50% up to 4% employee contribution3 weeks’ vacation plus 4 floater days5 personal time-off days5 Sick days2 company-paid volunteer days per calendar yearAccessibility for Ontarians with Disabilities Act StatementAs 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.Live EngagementWe provide an inclusive work environment where each person is considered as an individual. If you require any accommodation at any point in the recruitment process, please let us know and we will work with you in an effort to ensure that you are able to fully participate in the process.#J-18808-Ljbffr

📌 Medtech Quality Systems & Compliance Specialist - C$65,000 - C$103,500 A Year (Winnipeg)
🏢 Johnson & Johnson
📍 Winnipeg