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
- University degree in Science, Engineering or related field
- Minimum 3+ years experience in regulatory affairs and/or quality assurance
- 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)
- Strong oral and written communication skills
- High standard of integrity, ability to meet deadlines, organized and able to prioritize tasks
- Post-graduate diploma in Regulatory Affairs or Quality Assurance
- Experience with Trackwise
- Experience with ComplianceWire
- Project management and report writing experience
- Medical device and/or pharmaceutical experience
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
Inari Medical Insights
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
