Work Flexibility: Hybrid
Stryker is currently seeking a Post Market Specialist in Waterdown, Ontario, CA! In this role, you will be responsible for ensuring regulatory compliance for post market activities and for the effectiveness of the Quality Management System for Stryker Canada. This individual must serve as a contributing member of the Post Market Team while championing Stryker’s Mission and Values.
Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility in Waterdown, Ontario, CA. You should be comfortable working two days onsite.
Responsibilities
Individual Responsibilities:
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Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation
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Responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance
Functional Responsibilities:
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Conduct product incident follow up, including filing necessary reports with manufacturers and Health Canada in accordance with the Canadian regulations for medical devices, CTOs, cosmetics, drugs, and natural health products
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Coordinates voluntary recalls in accordance with the Canadian regulations for medical devices, CTOs, cosmetics, drugs, and natural health products
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Monitor customer complaints for adverse trends and analyze data to identify opportunities to reduce complaints and improve customer satisfaction
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Support the Quality Management System and operate as a resource for the ISO 9001 Standard and Good Manufacturing Practices requirements for Stryker Canada
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Support the annual internal audit and self-inspection programs and participate in internal audits, as required
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Participate in Third Party Audits and follow up on Corrective Actions
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Coordinate the document control process by ensuring change control and record retention requirements are met.
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Liaise with Corporate RAQA Managers on behalf of Stryker Canada
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Work with all areas within the company (Sales, Operations, and Marketing)
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Work with all regulatory affairs and quality assurance personnel at all manufacturing sites
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Builds good rapport with Health Canada
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Other duties as assigned by Manager
Conduct & Compliance
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Abide by and support the policies set forth in the Stryker Code of Conduct
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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
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Conduct work in compliance with all laws, rules, and regulations and in accordance with Stryker’s high ethical standards
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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
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Working knowledge of Canadian Medical Device Regulations and ISO 9001 Standard. Knowledge of Health Canada regulations for Drugs, NHPs, Cosmetics, and Cells, Tissues, and Organs a benefit.
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Strong computer skills (Excel, Word, Power Point, Share point)
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High standard of integrity and ability to meet deadlines
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Highly organized and able to prioritize tasks
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Strong oral and written communication skills with both internal and external contacts
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Ability to make and support decisions with regards to regulatory and quality issues
Education & Qualifications
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University Degree Required. In a science or related field preferred.
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Post-graduate diploma in Regulatory Affairs or Quality Assurance Preferred (completed or in-process)
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At least one year of experience in a regulatory affairs and quality assurance environment an asset
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Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered
Travel Percentage: 10%
