This position is responsible for the ongoing support and maintenance of the Quality Management System, focusing on quality compliance in the areas of GMPs and document control for Stryker Canada. This individual must serve as a contributing member of the QA team while championing Stryker’s Mission and Values.

Responsibilities

Individual Responsibilities:

• Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation
• Responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance

Functional Responsibilities:

• Responsible for GMP, GDP and regulatory requirements while ensuring quality standards are met throughout the organization
• Conducts regular inspections of the distribution facility, including documentation and reporting of findings
• Monitor distribution environmental program
• Review QA documentation to ensure compliance (eg OOS, deviations, CAPA, change control)
• Conduct new hire GMP orientation training.
• Develop and maintain a documentation system to ensure compliance with approved process and procedures.
• Ensure that the document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS.
• Ensure quality records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records
• Support the Quality Management System and operate as a resource for the ISO 9001 Standard for Stryker Canada
• Participate in Third Party Audits and support Corrective Actions
• Establishes and cultivates a wide range of collaborative business relationships to facilitate completion of assignments
• 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

• Knowledge of GMPs and Health Canada regulations regarding drugs and natural health products
• Knowledge of Canadian Medical Device Regulations and ISO 9001 Standard
• Strong computer skills (Excel, Word, Power Point, Share point)
• 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
• Ability to make and support decisions with regards to regulatory and quality issues

Education & Qualifications

• University Degree in Science required
• Post-graduate diploma in Regulatory Affairs or Quality Assurance Preferred (completed or in-process)
• At least one year of experience in a regulatory affairs and quality assurance environment an asset
• Pharmaceutical, healthcare or food industry experience - Preferred
• Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered