Quality Engineer Job

· Follow the GMP and GDP practices during the execution of the protocols and preparing the Qualification documents.

· Represent validation during the creation of Validation Strategy Documents and other project related documentation.

· Use Root Cause Analysis to investigate the problem and find the resolution for problems.

· Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.

· Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.

· Prepare FMEA’s, control plans, quality plans, PPAP.

· Supporting the MRB and RMA processes.

· Generating applicable quality metric reports; cost of quality, management by facts.

· Perform continuous improvements by developing best and proven practices in the department based upon current industry.

· Initiate and participate as appropriate in associated change control requests, deviations, and equipment acquisition documentation.

· Follow 21 CFR Part 11 regulations. Play a major role in performing part 11 assessment, especially contributing to the components involved in the maintenance of Electronic Records

· (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR part 11 regulations.

· Experience in Agile Implementation and Sprint Planning.

· Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.

Bachelor's Degree is required in Mechanical Engineering or Engineering Management or Industrial and Systems Engineering.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave