· 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.
· 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
· 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.
· 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.