Senior Specialist, Operations Quality
About the position
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
- 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
- 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
- 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
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)
- High standard of integrity and ability to meet deadlines
- Highly organized and able to prioritize tasks
- Strong oral and written communication skills with both internal and external contacts
- University degree in Science, Engineering or related field required
- Minimum 3+ years’ experience in regulatory affairs and/or quality assurance
Nice-to-haves
- Trackwise and ComplianceWire will be considered an asset
- Project management and report writing; preferable
- Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred
- 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
Benefits
- None
