Are you looking for a technical opportunity where you can be part of a growing industry? Our client in the contract manufacturing space needs a dynamic Quality Engineer to join their growing team in Pittsfield, MA area. This direct hire position offers growth and a great benefits program.
Quality Representative Leader in new product development projects which focuses on validation of implantable and non-implantable plastic medical devices and supporting equipment’s.
Responsibilities of Quality Engineer
• Develop and approve validation strategies, (Installation Qualification, Operational Qualification, Performance Qualification, Equipment Installation Qualification, Design of Experiment, Gage R&R) protocols and reports for products and equipment’s using engineering experience and statistical techniques.
• Work with Manufacturing Engineer and Lead Inspector prior to protocol executions and ensure expeditious and accurate completion of validation.
• Interact regularly with General Manager, QA Manager and customers on validation activities progress. Key Participant of weekly meetings with Project Manager, QA Manager and Manufacturing Engineer to update customer on validation activities.
• Conduct design of experiments and applies statistical techniques (T-test, control charts, Multi Vari charts, Process Capability (Cpk, Ppk), Gage “Repeatability & Reproducibility” (R&R) to improve molding processes capability and robustness.
• Maintain validation records to ensure compliance with current standards.
• Use flowchart to develop process and evaluate failure modes.
• Develop and Lead FMEA's and Production Control Plan.
• Summarize and evaluate protocol data involving resolution of discrepancies and exceptions as required for completion of validation summary reports.
• Balance successfully the workload of multiple projects simultaneously while assuring high quality deliverable with aggressive schedules.
• Plan, schedules inspection and test with QA Manager and evaluate the adequacy of activities to accomplish inspection objectives.
• Facilitate first piece inspection for new product development.
• Drive revalidation efforts to ensure systems continue to meet regulatory requirements
• Review, update and write all documents (such as work instructions, inspection instructions).
• Participate in Contract Reviews for validation documents
• Work with Manufacturing and Engineering/Tooling to identify and drive improvement opportunities.
• Act as a project leader for process improvement projects, conduct and/or review results of investigation analyses issues, and collect data, monitor and report process trends and control data, and coordinate product and process transfers.
• Assure quality programs are designed to achieve customer specification and continually evaluate quality assurance and/or control methods.
• Perform and Participate in 3rd party ISO 9001:2008 and ISO 13485:2003 audits (Risk Management). Conduct ISO 9001:2008 and ISO 13485:2003 internal Audits.
• Assure products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO and GMP standards.
Requirements of Quality Engineer:
• Bachelor’s Degree or equivalent, or 3-5 years’ related experience and/or training , or equivalent combination of education and experience in quality engineering in the medical industry
• Strong Computer skills; Microsoft Office ( Word, Excel) and Minitab
• Leadership skills and team player
• Ability to work with a high volume of documents in a fast paced environment
• Strong written , verbal , time management and interpersonal skills
• Knowledge of GD&T print interpretation , CAD Models , Statistical technique and Software , Programming CMM’s , Validation Activities ( IQ, OQ,PQ) , Cleanroom practices , Sampling Technique.
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. Apply today and experience “The DAVIS Difference”.