Senior Specialist, Operations Quality
This position is responsible for providing dedicated support to Operations to develop and maintain those areas of the quality management system in accordance with ISO standards, Good Manufacturing Practices (GMP), Stryker Corporate requirements, and Canadian regulatory requirements. This individual is responsible to support and ensure that effective and efficient quality practices are maintained in collaboration with Global Logistics & Operations (GLO). This individual must serve as a contributing member of the Quality Assurance team while championing Stryker’s Mission and Values.
Responsibilities:
Individual Responsibilities:
Proactively collaborates with internal and external stakeholders to promote a culture of inclusiveness and cooperation
Responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance
Functional Responsibilities:
Act as the key contact for Quality related activities within Operations for Stryker Canada
Identify improvements and inputs into the quality planning process
Represent QA and act as the QA stakeholder on Operations-led projects
Responsible for the review of programs and/or processes impacting the Quality Management System governing the distribution of regulated products within Canada
Identify and implement improvement opportunities to increase the efficiency and effectiveness of QMS related documents for Operations
Ensure quality records are established and maintained to provide evidence that the QMS is being followed
Implement and maintain the Validation Program in collaboration with Operations and GLO for Stryker Canada
Provide oversight for the development and/or execution of plans, protocols, reporting, training and quality system documents associated with validation requirements
Responsible for the support and review of NCs and CAPAs for Operations, with attention to detail, review for completeness of actions and records, accuracy, and effectivity, and timelines
Facilitate Operations teams in the application of problem-solving techniques and promote its uses and development (e.g. 5 Why's, fishbone diagrams, 4D’s, process mapping, etc.)
Support the creation of quality objectives/KPI’s for Operations, and provide support in meeting requirements/targets
Drive Good Manufacturing Practices and Good Documentation Practices within Operations
Other duties as assigned by Manager
Conduct & Compliance
Abide by and support the policies set forth in the Stryker Code of Conduct
Understand that compliance with the Code of Conduct, as it may be amended by Stryker Corporation from time to time, is a condition of continued employment with Stryker
Conduct work in compliance with all laws, rules, and regulations and in accordance with Stryker’s high ethical standards
Report any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker’s Ethics Hotline Policy
Knowledge & Skill Requirements
Working knowledge of ISO 9001 requirements
Working knowledge of Canadian regulations for medical devices, CTO (cells, tissues, and organs), drugs, natural health products, and cosmetics
Strong computer skills (Excel, Word, Power Point, SharePoint), Trackwise and ComplianceWire will be considered an asset
High standard of integrity and ability to meet deadlines
Highly organized and able to prioritize tasks
Project management and report writing; preferable
Strong oral and written communication skills with both internal and external contacts
Education & Qualifications
University degree in Science, Engineering or related field required
Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred
Minimum 3+ years’ experience in regulatory affairs and/or quality assurance
Medical Device and/or Pharmaceutical experience is an asset
Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered
Canada Pay Ranges:
Canada: $72,400 - $96,600 CAD Annual
Travel Percentage: None
Skills Required
- Working knowledge of ISO 9001 requirements
- Working knowledge of Canadian regulations for medical devices, CTO, drugs, natural health products, and cosmetics
- Strong computer skills (Excel, Word, PowerPoint, SharePoint)
- Experience with TrackWise and ComplianceWire
- High standard of integrity and ability to meet deadlines
- Highly organized and able to prioritize tasks
- Project management and report writing
- Strong oral and written communication skills
- University degree in Science, Engineering or related field
- Post-graduate diploma in Regulatory Affairs or Quality Assurance
- Minimum 3+ years' experience in regulatory affairs and/or quality assurance
- Medical Device and/or Pharmaceutical experience
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
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Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
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Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.
Stryker Insights
What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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