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Form of workAre 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 RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
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
Stryker is hiring a Staff CAPA Specialist for our Medical division in Portage, MI. The Staff CAPA Specialist will be responsible for leading the NC/CAPA process to ensure compliance, efficiency, and effectiveness in meeting the goals and objectives of the business.
Who we want:
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
What you will do:
- Working within the QMS team, under general supervision, to ensure compliance to NC/CAPA processes and procedures and be responsible for, but not limited to:
- Reviewing and approving NC and CAPA records, with attention to detail - for completeness, accuracy, effectiveness and timeliness - including extension requests
- Collaborating with cross-functional partners to facilitate and mentor teams through all stages of the NC/CAPA process.
- Ensuring users provide the necessary rigor to the eCAPA system content including maintaining a live document with all relevant evidence attached in a timely manner.
- Facilitating and coaching NC & CAPA teams - as a problem-solving methodology expert - in the application of problem-solving techniques and promoting its use and development e.g. Human Error Reduction, 4-D etc.
- Being the NC/CAPA Process Owner and Subject Matter Expert ensuring compliance to the relevant Corporate and local procedures. Super user of eCAPA system.
- Leading the local GQ&O Quality Review Board (QRB) and working with local GQ&O site leaders to prepare for the site CAPA Review Board (CRB), the Franchise CRB, and Management Review.
- Collaborating with cross-functional partners to develop, maintain, and improve an effective, efficient, and compliant execution process to meet the NC/CAPA process effectiveness targets (i.e. time to priority, time to containment, RC & CA plan aging, etc)
- Monitoring site NC/CAPA KPIs, providing detailed updates, information, and analysis to site leaders in a timely and effective manner to allow any necessary escalations in order to meet monthly and yearly targets.
- Ensure adequate training is developed, maintained and provided to all users of the NC/CAPA process & systems.
- Acting as the GQ&O NC/CAPA Process Owner in all audits (internal, external, and Corporate), including preparing record requests, interfacing with auditors, and providing supporting evidence and rationale to support a fully compliant process.
- Collaborating with other site NC/CAPA Specialists and introducing/implementing best practices at local site
What you will need
Required:
- Bachelors degree required
- Minimum of 4 years’ experience in Quality systems or engineering.
Preferred:
- Bachelors degree in a Science or Engineering preferred
- Minimum of 2 years in regulated environment preferred.
- Strong knowledge of supporting Quality Systems (e.g. audits, management review, quality planning).
- Knowledge and understanding of Medical Device Regulations preferred.
- Highly developed problem-solving and analytical skills.
- Strong in critical thinking and "outside the box" thinking.
- Must possess strong communication (written and oral), interpersonal, and influencing skills.
- Ability to manage multiple tasks simultaneously and complete projects in a matrix organization.
- Demonstrated ability to work independently.
- Proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
About Stryker
Our benefits:
12 paid holidays annually
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
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 on our referral page
Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
