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Job description
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.