Quality Assurance Complaint Coordinator

Job Title:

Quality Assurance Complaint Coordinator

Responsibility:

·   Organize complaint evaluation with QRM (Quality and Regulatory Affairs Manager).

·   Coordinate complaint process with Department Managers.

·   Formulate and finalize QA statements for complaints.

·   Organize inspection of return goods and assessment of product for repacking, restocking or scrap.

·   Administration of IR process in regards to complaints.

·   Communication with Austrian and German QA/QC departments.

·   Communication with supplier regarding product improvements.

·   Support periodic reporting and statistical evaluations in regards to complaints.

·   Substitute in periodic complaint meetings for management.

·   Monitor complaints for recall situations and assist in reporting and administration of product recalls according to FDA/Canadian requirements.

·   Support internal performance evaluation (ex. blood draw, trials) according to valid procedures.

·   Organize and issue performance test reports.

·   Follow up on corrections and actions resulting from the complaint process.

·   Monitor complaint process and organize correction when needed.

·   Maintenance of complaint files, electronic and physical.

·   Cooperation with external laboratories for testing together with QRM.

·   Other duties as assigned. 

Authority:

 

·   Evaluate and decide on acceptance or rejection of QA/QC and IR testing reports.

·   Accept or reject corrections in regards to complaints together with QRM. 

·   Formulate and sign final QA statement based on testing results.

·   Close and finalize complaints according to QMI 13.03.

·   Organize periodic complaint meetings.

·   Assign risk according to valid procedure

·   Issue, review, revise and train on QM documents in accordance with QMI 05.01.

·  Assist with administration of internal audits 

Job Requirements:

 

·   MedTech education or College degree in biology, chemistry, biotechnology prefered.

·   QA experience in a laboratory in a leading position is beneficial.

·   Must have excellent communication and writing skills.

·   Proficient computer skills.

·   Must have good Organizational skills. 

·   Must be detail oriented and accurate.

·   ISO 9001 or ISO 13485 experience is beneficial.

·   Must pass pre-employment examination, qualification test.

Physical Requirements:

·   Must be able to sit for up to 8 hours.

·   Must have appropriate vision to perform detailed quality inspections as outlined in SOPs and TPs.

 

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law.

 

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