Senior Specialist, QMS

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Why regulatory affairs/quality assurance at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Specialist, QMS located in Michigan, Kalamazoo.

Who we want:

• Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

The Senior Specialist, QMS will primarily be responsible for the oversight & assessment of changes to the quality management system. They will oversee and ensure that changes to our quality management system processes and procedures are compliant, effective and pose no risk to the quality of the product/processes. They will work within the QMS team, under general supervision, to ensure compliance to Change Control processes and procedures and is responsible for, but not limited to.

• Leading & executing the change control board review forums. Participate in multi-site and global forums.
• Liaise with relevant functional groups, facilitate and mentor teams through all stages of the change control process. Supports and coaches the change owners and initiators.
• Act as change analyst & approver, have responsibility for review and approval changes to processes and procedures, with attention to detail, review for completeness, accuracy, effectivity and appropriateness
• Conduct reviews for sound rationale, challenging justification, correct approval and oversight and resulting status of change requests.
• Ensuring users provide the necessary rigor to the PLM system content including maintaining a live document with all relevant evidence attached, in a timely manner.
• Act as a Subject Matter Expert on all related procedures and process SME, ensuring compliance to the relevant corporate procedures. Super user of PLM system.
• Ensure adequate training is developed, maintained and provided to all users of change control process & systems.
• Manage & monitor site Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other GQO sites to ensure compliance to global requirements & metrics are achieved
• Interface between divisions & GQO sites, and functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.
• Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
• Lead &/or participate in cross-plant and corporate project teams in areas of change management and quality systems improvement.
• Lead/coordinate preparation, participate and follow up to Stryker Internal, Corporate and third party compliance audits.

What you need:

• Bachelor’s degree (emphasis in engineering, sciences, quality or related discipline preferred).
• Quality and/or regulatory affairs certifications such as RAC, CQA, CQE, etc. are preferred.
• 4+ years or more of experience in the medical device industry or an equivalent regulated environment, with a focus on quality systems and / or regulatory affairs.
• Thorough knowledge and understanding of US and international medical device regulations, including those of the EU and MDSAP regions.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com