Senior CAPA Analyst (Hybrid or Remote)

Stryker is hiring a Senior CAPA Analyst (Hybrid or Remote) in San Jose, California, to support Endoscopy, responsible for overseeing the NC/CAPA process and procedures to ensure they are compliant, effective, and efficient in dealing with quality issues. In addition, you will facilitate proactive and effective resolution of issues through building expertise in problem-solving methodology.

Work Flexibility: Hybrid or Remote. It is preferred that this person is in reasonable proximity to our Stryker facility in San Jose, California; however, we are open to remote.

Who we want:

• Dedicated achievers. 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:

• Ensure compliance to CAPA processes and procedures

• Develop/review metrics for adverse trending analysis of non-conformities.

• 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.

• 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.

• 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.).

• Lead local NC/CAPA review board forums, may participate in global forums

• Customizes Queries from eCAPA system and analyzes data based on KPIs to organize work

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

• Monitor and drive completion of records to ensure on-time execution

• Identify and lead local continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for the improvement and optimization of business processes and results.

• Coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third party audit activities.  Participate in Front Room Audit Capacities

• Update local/ suggest updates to Global Procedures

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

• Delivers training and coaching for new CAPA team members on principles and system requirements.

• Participate in cross-site and corporate project teams in areas of CAPA and quality system improvement, may act as DPO

• Utilize basic project management techniques

What you need:

Required:

• Bachelor of Science in Engineering or related discipline

• 2  years’ experience in CAPA, Quality, Regulatory, Engineering or Equivalent Role

Preferred:

• 3 experience in manufacturing environment

• Experience in interacting with regulatory agencies (FDA, Notified Body, etc.)

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

• Knowledge of other QMS elements related to CAPA

• Proficient in Microsoft Office, TrackWise

• Experience working in a compliance-risk situation

• Highly developed problem-solving skills

• Must possess the ability to manage multiple tasks simultaneously.

• Strong interpersonal skills, with demonstrated ability to manage and interact with multiple stakeholders at different levels and areas of global organization.

$65,400 - $132,300 salary plus bonus eligible Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data.  Actual minimum and maximum may vary based location.  Individual pay is based on skills, experience, and other relevant factors.