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Senior CAPA Analyst in San Jose, CA at Stryker Corporation

Date Posted: 4/4/2019

Job Snapshot

Job Description

Who we want

  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • 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. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As a Senior CAPA Analyst your primarily responsible is the oversight of NC/CAPA process and procedures, ensuring they are compliant, effective, and efficient in dealing with quality issues. You must be proactive and effective in resolution of issues and comfortable using problem-solving methodologies.

  • You will ensure compliance to CAPA processes and procedures
  • You will develop/review metrics for adverse trending analysis of non-conformities.
  • You will 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.
  • You will be 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.
  • You will 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.).
  • You will lead local NC/CAPA review board forums, may participate in global forums
  • Act as a subject matter expert for eCAPA and CAPA procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
  • Identify and lead local continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports
  • Coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third-party audit activities.  Participate in Front Room Audit Capacities
  • Deliver training and coaching for new CAPA users and 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

What you need

  • Bachelor’s degree – preferred in Engineering or related
  • 3 + years’ experience in manufacturing environment – preferred experience within CAPA, Quality, Regulatory or Engineering
  • Experience in interacting with regulatory agencies (FDA, Notified Body, etc.)
  • Demonstrated knowledge of U.S., European, and international regulatory industry guidelines/standards (EN ISO 13485, 21 CFR 820, etc) and ability to interpret and apply.
  • Proficient in Microsoft Office, TrackWise

Work From Home: No

Travel Percentage: None

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.

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