Quality Management System Specialist

2 weeks ago

Waterdown, Canada Stryker Full time

Stryker is hiring a **Quality Management System Specialist (Hybrid) **in **Waterdown, **Ontario, CA.**

As a QMS Specialist, you will be responsible for overseeing, supporting, and ensuring that an effective and efficient quality management system is built and maintained according to ISO9001, Good Manufacturing Practices (GMP), and internal Stryker Corporate and Canadian requirements. This individual must serve as a contributing member of the Quality Assurance 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 at least one day onsite.

**Who we want**:

- ** Collaborative Partners.** People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- ** Dedicated achievers.** Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

**What you will do**:

- Responsible for compliance with the ISO 9001 standard for Canada.
- Responsible for compliance with Canadian Good Manufacturing Practices for Drugs and Natural Health Products
- Develop and maintain the QMS and documentation system to ensure compliance with approved process and procedures.
- Engage in the development of optimum future state of QMS for business needs.
- Identify improvements and inputs into the quality planning process.
- 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.
- Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with internal and external requirements, standards, and regulations
- Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, and effectiveness. Work with process owners to ensure timely CAPA investigation and closure.
- Implement and maintain an Internal Quality Audit and Self-Inspection program covering all processes, products, and regulations within scope.
- Define and implement a QMS training program, which includes GMP training for drugs and natural health products. Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary.
- Support Management Review and Quality Planning Review and related forums to ensure and monitor QMS suitability, adequacy and effectiveness.
- Liaise with the external assessment body on all matters related to the external certification process.
- Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources
- Support departmental process owners to identify, implement and document improvement opportunities.
- Assist in creation of quality objectives/KPI’s for QA and non-QA departments
- Partner with RA/QA to establish best practice and standardize processes where possible.
- When requested, provide support to other members of RAQA team to facilitate the meeting of their requirements / targets.

**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

**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 ISO9001 Requirements
- Working knowledge of Canadian GMP requirements for Drugs and Natural Health Products
- 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 de

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