Staff Specialist, CAPA (Hybrid)

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Staff Specialist, CAPA in San Jose, CA, home to Stryker's Endoscopy division! As a Staff Specialist, you will be responsible for the oversight of the CAPA process and procedures and ensure it is compliant, effective, and efficient in dealing with quality issues. You will also facilitate proactive and effective resolution of issues through expertise in problem-solving methodology.

Who we want:

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, 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.

What you will do:

• Working collaboratively within the QMS team, you will ensure compliance to CAPA processes and procedures.
• Review and approve NC and CAPAs, with attention to detail, and review for completeness, accuracy, effectivity, and timeliness. Review & Approval of CAPA changes, including extension requests.
• Liaise with relevant functional groups, facilitate, and mentor teams through all stages of the NC / CAPA process.
• Contribute to developing optimum future state of the NC / CAPA process for business needs, aligned with Corporate
• Develop & deliver training and coaching for new CAPA users on CAPA principles and on the system
• Coordinate between potential different organizations which have to interface
• 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.
• As Problem Solving Methodology expert, facilitate and coach NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
• Subject Matter Expert on all related procedures, ensuring compliance to the relevant corporate procedures. Super user of eCAPA system.
• Lead & execute the NC/CAPA Review board forums. Chair and lead Global/ multi-site forums.
• Manage & monitor site NC/CAPA 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.
• Ensure adequate training is developed, maintained, and provided to all users of CAPA process & systems.
• Identify and lead continuous improvement and collaboration opportunities, promoting the development and implementation of quality data and reports for improvement and optimization of business processes/results.
• Provides review and input into global procedures.
• Identify opportunities for improvement, lead &/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
• Lead/coordinate preparation, participate, and follow up on Stryker Internal, Corporate, and third-party compliance audits.

What you need

Required

• Bachelor's degree in a Science, Engineering, or related discipline.
• 4+ years of experience in the area of quality systems or engineering or equivalent experience, with a minimum of 2 years of experience in the area of CAPA.

Preferred

• Master's degree in Engineering preferred
• Experience working in a Quality/Regulatory Affairs environment preferred
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)

Travel Percentage: 20%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.