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 productive 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

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📌 Senior Specialist, Operations Quality (Ontario)
🏢 Stryker Group
📍 Ontario