Senior Specialist, Operations Quality
Stryker
Senior Specialist, Operations Quality
Job Description
Work Flexibility: HybridSenior Specialist, Operations QualityThis 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 cooperationResponsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and PerformanceFunctional Responsibilities: Act as the key contact for Quality related activities within Operations for Stryker CanadaIdentify improvements and inputs into the quality planning processRepresent QA and act as the QA stakeholder on Operations-led projectsResponsible for the review of programs and/or processes impacting the Quality Management System governing the distribution of regulated products within CanadaIdentify and implement improvement opportunities to increase the efficiency and effectiveness of QMS related documents for OperationsEnsure quality records are established and maintained to provide evidence that the QMS is being followedImplement and maintain the Validation Program in collaboration with Operations and GLO for Stryker CanadaProvide oversight for the development and/or execution of plans, protocols, reporting, training and quality system documents associated with validation requirementsResponsible 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 timelinesFacilitate 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/targetsDrive Good Manufacturing Practices and Good Documentation Practices within OperationsOther duties as assigned by ManagerConduct & ComplianceAbide by and support the policies set forth in the Stryker Code of ConductUnderstand 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 StrykerConduct work in compliance with all laws, rules, and regulations and in accordance with Stryker’s high ethical standardsReport any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker’s Ethics Hotline PolicyKnowledge & Skill RequirementsWorking knowledge of ISO 9001 requirementsWorking knowledge of Canadian regulations for medical devices, CTO (cells, tissues, and organs), drugs, natural health products, and cosmeticsStrong computer skills (Excel, Word, Power Point, SharePoint), Trackwise and ComplianceWire will be considered an assetHigh standard of integrity and ability to meet deadlinesHighly organized and able to prioritize tasksProject management and report writing; preferableStrong oral and written communication skills with both internal and external contactsEducation & QualificationsUniversity degree in Science, Engineering or related field requiredPost-graduate diploma in Regulatory Affairs or Quality Assurance preferredMinimum 3+ years’ experience in regulatory affairs and/or quality assuranceMedical Device and/or Pharmaceutical experience is an assetInternal 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
Locations
- Canada, Hamilton
Salary
72,400 - 96,600 USD / yearly
Skills Required
- ISO 9001 requirementsintermediate
- Canadian regulations for medical devicesintermediate
- regulatory affairs and/or quality assuranceintermediate
Required Qualifications
- Working knowledge of ISO 9001 requirements (experience)
- Working knowledge of Canadian regulations for medical devices, CTO (cells, tissues, and organs), drugs, natural health products, and cosmetics (experience)
- Strong computer skills (Excel, Word, Power Point, SharePoint), Trackwise and ComplianceWire will be considered an asset (experience)
- High standard of integrity and ability to meet deadlines (experience)
- Highly organized and able to prioritize tasks (experience)
- Project management and report writing; preferable (experience)
- Strong oral and written communication skills with both internal and external contacts (experience)
- Working knowledge of Canadian regulations for medical devices, CTO (cells, tissues, and organs), drugs, natural health products, and cosmetics (experience)
- Strong computer skills (Excel, Word, Power Point, SharePoint), Trackwise and ComplianceWire will be considered an asset (experience)
- High standard of integrity and ability to meet deadlines (experience)
- Highly organized and able to prioritize tasks (experience)
- Project management and report writing; preferable (experience)
- Strong oral and written communication skills with both internal and external contacts (experience)
- University degree in Science, Engineering or related field required (degree in science)
- Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred (experience)
- Minimum 3+ years’ experience in regulatory affairs and/or quality assurance (experience, 3 years)
- Medical Device and/or Pharmaceutical experience is an asset (experience)
- Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered (experience)
- University degree in Science, Engineering or related field required (degree in science)
- Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred (experience)
- Minimum 3+ years’ experience in regulatory affairs and/or quality assurance (experience, 3 years)
- Medical Device and/or Pharmaceutical experience is an asset (experience)
- Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered (experience)
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
- 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
- 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
Benefits
- general: Canada: $72,400 - $96,600 CAD Annual
- general: Canada: $72,400 - $96,600 CAD Annual
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