· 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.
Internal Number: 1437
About Greiner Bio-One N.A.
Located in Monroe, North Carolina, we provide product manufacturing, distribution logistics and production application support to our customers in Life Science and Clinical laboratories through our BioScience and PreAnyalitic business units.
The BioScience business operation of Greiner Bio-One offers products for the cultivation and analysis of cell and tissue cultures, micro-plates for high-throughput screening, allowing industry and research the most rapid and efficient drug screening, a complete line of dependable ready-to-use general lab-ware tools used in laboratories everywhere, and innovative bio-chip technologies for genotyping to detect gene defects and identify infectious agents.
The PreAnalytic business unit at Greiner Bio-One offers solutions for the collection of human samples under the VACUETTE brand name. Our products are designed in close cooperation with customers, and manufactured to meet the regulations of FDA QSR and cGMP, Health Canada and ISO 13485. Our products and the service we provide are geared toward the daily routine of laboratory medicine.
Greiner Bio-One, developed and sold the first plastic evacuation blood collection tube on the market to p...rovide Phlebotomy, Nursing, and Laboratory professionals with a new level of safety and product effectiveness that would help to eliminate the use of dangerous glass tubes. This level of service to the safety of the medical professional continues today in the products we bring to customers. Our products have extensive clinical backing along with educational programs and materials to help assure our customers that they will deliver the best possible results for their patients.