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 Whys fishbone diagrams 4Ds process mapping etc.)

• Support the creation of quality objectives/KPIs 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 Strykers high ethical standards

• Report any violations of these policies and procedures to Stryker management or in the manner outlined in Strykers 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