Quality Assurance Complaint Specialist

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.