We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)

Stryker is hiring a Quality Systems Specialist, NC/CAPA (Hybrid) in Redmond, Washington to support Medical! In this role, you will be responsible for the oversight of the NC/CAPA process and procedures, and ensure it is compliant, effective, and efficiency in dealing with quality issues. Additionally, you will facilitate proactive and effective resolution of issues through building expertise in problem-solving methodology.

Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility in Redmond. You should be comfortable working 3 days onsite.

What you will do:

• Ensure compliance to CAPA processes and procedures.

• Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, effectivity, and timeliness.

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

• 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.

• Exhibit ability to build expertise in facilitating NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, 5 Why's, fishbone diagrams, process mapping, etc.)

• Highly proficient in NC/CAPA procedure requirements and serves as eCAPA super-user.

• Execute the NC/CAPA review board forums.

• Monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality and business review forums, ensure compliance to global requirements and metrics are achieved.

• Identify continuous improvement and collaboration opportunities.

• Engage in cross-site and corporate project teams in NC/CAPA area of expertise.

• Coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third party audit activities.

What you need:

Required:

• Bachelor’s Degree in a science, engineering or related discipline.

• 0+ related experience.

Preferred:

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

• Ability to gain knowledge and understanding of U.S. and International medical device regulations.

• Ability to gain knowledge in supporting Quality Systems (audits, management review, quality planning, etc.)

• Exhibit strong communication and influencing skills and have the ability to manage multiple tasks simultaneously.

• Exhibited analytical and problem-solving skills.

• Comfort working in a compliance-risk situation.

$67,500.00 --$104,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.