Senior Specialist, Quality Management System

Job Overview

This position is responsible for the development 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 for oversight, support, and ensuring that an effective and efficient quality management system is built and maintained. 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:

• Support Quality Management System (QMS) compliance with the appropriate internal and external regulatory requirements (including but not limited ISO 9001, Stryker Corporate, Stryker Canada, and Health Canada requirements)
• Contribute to the development of optimum future state of the QMS for business needs
• Identify improvements and inputs into the quality planning process
• Oversee and execute development and/or modification of Stryker Canada’s QMS
• Support Management Review and Quality Planning Review and related forums to ensure and monitor QMS suitability, adequacy and effectiveness
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS
• Ensure quality records are established and maintained to provide evidence that the QMS is being followed
• Implement and maintain the internal audit and self-inspection programs covering all processes, products, and regulations within scope of the QMS
• Liaise with external assessment bodies and health authorities on all matters related to the   external certification process and compliance to the Canadian regulations
• Responsible for review and approval of NCs and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, and effectivity, and timelines along with review and approval of CAPA changes and extension requests
• Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process
• Ensure rigor to the eCAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner
• Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 5 Why's, fishbone diagrams, 4D’s, process mapping, etc.)
• Provide leadership to drive behaviours through the use of accountability meetings and facilitate root cause analysis workshops with process owners to ensure timely CAPA investigation and closure.
• Lead and execute the NC/CAPA review board and maintenance for relevant KPIs
• Support the creation of quality objectives/KPI’s across the business, and provide support in meeting requirements/targets
• Contribute to the development, maintenance, and improvements of policies and procedures
• Implement best-in-class practices and benchmark against industry and regulatory requirements
• Drive Good Manufacturing Practices and Good Documentation Practices within the organization
• 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
• Ability to make and support decisions with regards to regulatory and quality issues

Education & Qualifications

• University Degree required
• Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred
• Minimum 3+ years’ experience in regulatory affairs and/or quality assurance
• Experience in regulated environment and interaction with auditing authorities and health authorities required
• Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered