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QA Complaint Investigator - In-Vitro Diagnostics
Ref No.: 18-32338
Location: Kalamazoo, Michigan
Skill Type
Skill Type:Professional
Key Responsibilities:
  • Responsible for the customer complaint handling process, including logging complaints and performing and writing investigations.
  • Responsible for the initial QA review of a customer complaint and requesting initial follow up information/facts from Customer/Technical Services or the Distributor as required.
  • Responsible for monitoring the progress of complaint handling and investigation, and working with applicable individuals and departments to ensure complaint handling time requirements are met.
  • Responsible for tracking and trending complaints and preparing complaint analysis reports, highlighting any adverse trends.
  • Responsible for highlighting any potential reportable events to QA/RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures.
  • Responsible for the CAPA process, ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy.
  • Responsible for coordinating and capturing records of the Material Review Board, Quality Review Board, CAPA Review Board and other such reviews pertaining to the CAPA system.
  • Responsible for establishing and maintaining training materials for effective nonconformance handling, root cause analysis, CAPA handling; complaint handling and delivering such training to users of the applicable process.
  • Responsible for monitoring the progress of nonconformance investigation and each stage of the CAPA process e.g. CAPA determination & approval, CAPA implementation and CAPA effectiveness checks; capturing and reporting metrics and highlighting to management when CAPA processing target times are not being met.
  • Responsible for preparing & presenting data/reports regarding CAPA metrics (e.g. cycle times, number open, % effectiveness) for submission to Site, Divisional and Corporate Management Review.
  • Responsible for planning & performing nonconformance investigations when required.
  • Responsible for planning & performing effectiveness checks on CAPA when required.
  • Responsible for contributing to the continual quality & reliability improvement of APD products and services.
  • Ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy.
  • Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
Minimum Requirements/Qualifications:
  • Associates Degree required, with Bachelor's Degree a strong preference
  • Minimum 2 years of experience working within a QA/RA department.
  • Experience of working with FDA regulated products (Medical Device/IVD preferred) (pharmaceutical or dietary supplement experience is acceptable).
  • Knowledge of ISO13485 / FDA QSR Part 820 / 803 requirements preferred
  • Experience working with complaint handling and/or CAPA & management review.
  • Knowledge of statistical data analysis tools and techniques.
  • Excellent interpersonal skills
  • Ability to work in a timeline driven environment
  • Excellent communication skills both written & oral
  • Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel)