CAPA Specialist in Kalamazoo, MI at Stryker Corporation

Date Posted: 10/8/2018

Job Snapshot

Job Description

Basic Function

Responsible for administering and managing the CAPA system to ensure effective operation as well as facilitating the Current Product Improvement Team (CPIT) process. 

Responsibilities

  • Interact with FDA and other regulatory agencies relating to non-conformance (NC) and CAPA.
  • Ensure compliance to Quality System Regulations (QSR) and ISO-13485 requirements for NC and CAPA
  • Create and revise procedures relating to NC and CAPA systems
  • Conduct training on NC and CAPA systems and procedures
  • Develop and improve NC and CAPA metrics
  • Facilitate the CPIT and CRB (CAPA Review Board) meetings
  • Prepare and presents reports on CAPA metrics
  • Provide guidance for using CAPA related tools and processes, including leading root cause investigations and effectiveness check follow-ups
  • Determine need for escalation of NCs to CAPAs
  • Review NCs and CAPAs for completeness and accuracy
  • Mentoring and coaching engineers on the CAPA process
  • Mentoring on problem solving methodologies

Blood Borne Pathogen Category A Position

Physical Requirements

  • Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force to lift, carry, etc.
  • Ability to operate common office equipment (e.g. calculator, PC, telephone. etc.)
  • Ability to operate in a fast paced environment, sometimes requiring extended work hours.

Mental Requirements

  • Must be able to make important non-conformance escalation decisions regarding risk to health, compliance, and business
  • Must be able to read and analyze prints, schematics, and GD&T and understand engineering principles
  • Must be able to plan, organize, and implement multiple concurrent tasks
  • Must be able to review high volume of non-conformance on weekly basis
  • Must be able to communicate at multiple levels of the organization
  • Must be able to communicate with multiple manufacturing sites and divisions
  • Must be able to effectively influence without direct authority

Qualifications/Work Experience Preferred

  • Excellent analytical and writing skills
  • Effective interpersonal communication skills
  • Effective organizational skills
  • Effective PC skills
  • Demonstrated ability to facilitate discussions
  • Demonstrated ability to correctly interpret technical information
  • Demonstrated ability to understand plant processes
  • Demonstrated ability to understand regulatory requirements
  • Demonstrated ability to understand procedures affecting plant operations
  • 3-5 years engineering, quality, regulatory, and/or management experience

Education/Special Training Required - B.A. or B.S in sciences or other technical field.  Engineering degree preferred.

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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