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Epredia Quality Engineer – Complaint Investigator in Kalamazoo, Michigan

At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.

SUMMARY

This position investigates consumable product customer complaints, providing a key interface between Customer/Technical Services and the QA/Operations/Engineering complaint investigation teams. This position takes responsibility for the tracking & trending of medical device/instrument based customer complaints and the provision of data, charts and reports for management review.

RESPONSIBILITIES

  • Initial QA review of a consumable product customer complaints and requesting initial follow up information/facts from Customer/Technical Services or the Distributor as required

  • Own customer complaint handling process, including performing initial assessments to determine potential reportability

  • Responsible for the maintenance of data and reporting of key trends in the electronic complaint handling system

  • Train appropriate individuals in the proper use of the electronic complaint management system

  • Drive and monitor the progress of complaint handling and investigations, and work with applicable individuals and departments to ensure complaint handling time requirements are met

  • Track trending complaints and preparing complaint analysis reports, highlighting any adverse trends

  • Highlight any potential reportable events to QA and/or RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures

  • Prepare & present data/reports regarding complaint metrics for submission to Site, Divisional and Corporate Management Review

  • Plan & perform nonconformance investigations when required--may include coordinating the return of product involved in investigations back to the supplier for further investigation

  • Contribute to the continual quality & reliability improvement products

  • Support internal and external audits

  • Ensure policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of customers & Quality Policy

  • Support the quality system and quality policy as directed by QA management

QUALIFICATIONS

  • Bachelor’s Degree or an Associate’s Degree with 5+ years of relevant work experience required

  • Knowledge of quality systems or 3+ years of experience in a quality management system

  • Working knowledge of quality systems (ISO 13485, ISO 9001, IATF 16949, FDA 21CFR820)

  • Experience working with FDA regulated products (Medical Device/IVDR preferred) (pharmaceutical or dietary supplement experience is acceptable)

  • Experience working with suppliers and/or customers

  • Knowledge of statistical data analysis tools and techniques

  • Ability to deliver, meet deadlines and have results orientation

  • Organized and able to use and contribute to existing record keeping systems

  • Excellent interpersonal skills

  • Able to communicate both orally and in written form to multiple levels of the company

  • Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel)

PREFERRED

  • Experience with SAP and Veeva

  • Background and/or experience with Histology or Chemistry

  • General knowledge of manufacturing process

  • Working knowledge of blueprint reading and geometric dimensioning and tolerancing

  • Knowledge of statistics, manufacturing process control and validation, and process capability

YOUR APPLICATION:

Epredia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.

TO ALL RECRUITMENT AGENCIES:

Epredia does not accept unsolicited third party resumes.

Epredia is an Equal Opportunity Employer including Disability/Protected Veterans (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) .

If you are interested in applying for employment with Epredia and need special assistance or an accommodation to use our website, please contact us at ApplicantAccommodations@epredia.com (ApplicantAccommodations@ascensia.com)

At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.

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