Specialist, Quality Assurance

3 weeks ago

Hamilton, Canada Stryker Corporation Full time

**Job Overview**

This position is responsible for the ongoing support and maintenance of the Quality Management System, through GMP and QA related activities, acting in compliance to drug, natural health product, medical device, cosmetic and CTO regulations. 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**:

- To act as a qualified person (as defined under section C.02.006 ofthe Food and Drugs Regulations and section 51 of the Natural Health Product Regulations) in the release of finished product.
- Conducts batch record review and determination of batch status (e.g., release, reject, or product hold for further clarification or investigation)
- Reviews audit trails and other data sources required to support batch record release
- Reviews QA documentation to ensure compliance (e.g., non-conformances, OOS, deviations, CAPA, change control, etc.)
- Performs quality assessments of finished product returns from the market for disposition
- Coordinates the testing of finished products to determine compliance with specifications
- Supports quality processes for storage and distribution of healthcare products
- Assesses potential impact of incidents and processing deviations on the quality and suitability of the product for sale, in partnership with the fabricator/supplier
- Reviews Annual Product Quality Reports (APQRs) and Annual Stability Reviews (ASRs) to verify ongoing suitability and compliance of finished products
- Ensures 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
- To establish and maintain validation program and documentation reviews
- Support the Quality Management System and operate as a resource for the ISO 9001 Standard and GMP regulations 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)
- Minimum of 1 year of experience in a regulatory affairs and quality assurance, operations environment (preferred)
- 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

**About Stryker

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