NC/CAPA Specialist in Tijuana at Stryker Corporation

Date Posted: 10/22/2018

Job Snapshot

Job Description

The following is not intended to represent an all-inclusive list of job responsibilities, but to outline the ESSENTIAL FUNCTIONS of the position.

Basic Function:

Responsible for administering and managing the CAPA system to ensure effective operation.

Responsibilities:

  • Facilitate the NCMB (Non Conformance Monitoring Board) and CRB (CAPA Review Board) meetings
  • Prepare and presents reports on CAPA metrics
  • Provide guidance for using CAPA related tools and processes
  • Determine need for escalation of CAPAs
  • Assist the process owner or designees in completing risk and resource assessments
  • Ensure consistency of risk assessments
  • Review and approve NCs and CAPAs  for completeness and accuracy
  • Owns the electronic system used to handle the NC/ CAPA Process

Supervisory Responsibilities:   

  • Mentoring and coaching associates on the CAPA process
  • Mentoring on problem solving methodologies

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-conformances 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

Required Skills:

  • Excellent analytical and technical writing skills in English and Spanish
  • Effective interpersonal communication skills
  • Effective organizational skills
  • Effective PC skills
  • Proficiency in the use and application of the Quality System Regulation requirements and related worldwide standards for medical devices
  • 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
  • Demonstrated problem solving and decision making skills.
  • Influencing skills within multifunctional teams

Required Experience:

  • 3-5 years engineering, quality, and/or regulatory experience  

Required Education and Training:

  • B.S. in electrical or mechanical engineering preferred or in science related technical field

Work From Home: No

Travel Percentage: None

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