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Senior CAPA Analyst in Mahwah, NJ at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

Job Description

Who we want

  • Analytic problem solvers that look at the details of an event and come up will innovative and detailed process solution. You should value relationships, ethics and data!

What you will do

As a Sr CAPA Analyst you will facilitate CAPA process and related activities. You will be responsible for creating CAPAs which includes monitoring and analyzing data and trending.  You will be expected to lead and/or support activities for process improvements and systems integration projects.

  • Ensure CAPA activities are effectively coordinated across all plants/locations.
  • Facilitate/participate in CAPA review meetings.
  • Ensure compliance to the Divisional CAPA process requirements across all plants.
  • Perform trending activities.
  • Maintain divisional metrics.
  • Communicate CAPA data and information to management.
  • Provide information, as appropriate, to feed into the corporate CAPA process.
  • Support Stryker Orthopaedics' continuous improvement initiatives.
  • Lead and participate in projects related to system integration and improvements to the electronic CAPA data system as it relates to CAPA.
  • Perform system administration activities in the electronic CAPA data system.
  • Perform and participate in divisional training on systems and/or processes related to CAPA system.
  • Actively promote a team approach to the CAPA process across all departments and all plants.

What you need

  • Bachelors in Engineering or related discipline
  • 5+ years of experience addressing Corrective Actions in a regulated industry
  • Demonstrated knowledge of Quality Management System requirements:  FDA Medical Device regulations (QSR) requirements, ISO 9001 / 13485, and applicable Medical Device Directives
  • Demonstrated ability to use Word, Excel, Visio, and Microsoft Project
  • Demonstrated ability to effectively apply problem solving techniques
  • Demonstrated ability to effectively facilitate meetings to determine root cause investigations and analysis
  • Demonstrated ability to work with electronic systems to complete/evaluate data analysis, trending, and system configuration
  • Demonstrated ability to collaborate with individuals across multiple plants/locations
  • Demonstrated ability to manage projects

Work From Home: No

Travel Percentage: Up to 25%

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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