Senior Specialist, Operations Quality

Stryker•Waterdown, ON

1d•CA$72,400 - CA$96,600•Hybrid

About The Position

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 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.

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)
High standard of integrity and ability to meet deadlines
Highly organized and able to prioritize tasks
Strong oral and written communication skills with both internal and external contacts
University degree in Science, Engineering or related field required
Minimum 3+ years’ experience in regulatory affairs and/or quality assurance

Nice To Haves

Trackwise and ComplianceWire will be considered an asset
Project management and report writing; preferable
Post-graduate diploma in Regulatory Affairs or Quality Assurance preferred
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

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
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
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