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Stryker is hiring a Staff CAPA Specialist (Hybrid) for our Medical division to support our former Sage Products location in Cary, Illinois where we design and manufacture products across the regulated spectrum (Medical Devices, Cosmetics and Pharmaceuticals). You will have the opportunity to influence various Quality System initiatives on our continuous process improvement journey. In this role, you will guide stakeholders through proactive and effective resolution of issues using your expertise and problem-solving methodology. You will shape and communicate effective strategies that support Stryker’s values of Integrity, Accountability, People and Performance.

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 initators. People who take ownership of their work and need no prompting to drive productivity, change, or outcomes.

• 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 future issues.

What you will do:

• Responsible for identifying and implementing significant systemic improvements within the NC/CAPA program

• Align NC/CAPA program strategy with QMS subsystem requirements

• Drive NCs and CAPAs to closure, using a systematic, project management approach

• Influence NC/CAPA owners to ensure timely and accurate completion of tasks in order to achieve compliance to global requirements and monthly metrics

• Lead and coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third-party audit activities, including disposition of findings using NC/CAPA tools

• Prioritizes improvement opportunities based on business needs into CAPA projects.

• Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.

• Develop and deliver training and coaching for new CAPA users on principles and system requirements.

• Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process.

• Contribute in development of optimum future state of the NC/CAPA process for business needs in alignment with Corporate direction.

• Ensure users provide necessary rigor to the eCAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner.

• Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, etc.).

• Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.

What you will need:

Required:

• Bachelor’s Degree is required

• Minimum of 4+ years’ experience in manufacturing, quality, engineering, or highly regulated environment with 2+ years in an FDA regulated environment.

Preferred:

• Bachelor’s Degree in Science, Engineering or related discipline

• 4+ years’ experience in area of CAPA, quality systems, engineering, or equivalent experience preferred.

• ASQ Six Sigma Certified or equivalent.

• Experience in interacting with regulatory agencies (FDA, MoH, BSI, TUV, etc.)

• Thorough knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply.

• Thorough knowledge and understanding of U.S. and International medical device regulations.

• Strong knowledge of supporting Quality Systems (audits, management review, quality planning, etc.)

• Experience with root cause and failure analysis.

• Ability to conduct and document technical investigations.

• Must possess strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.

• Strong technical writing skills

• Demonstrated ability to successfully manage and complete projects in a matrix organization.

• Experience working in a compliance-risk situation with successful outcomes.

• Computer literacy, including Microsoft Word, Excel and PowerPoint.

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. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.