Senior Specialist, Operations Quality

• 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