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Spectrum Plastics Group Quality Assurance Inspection Engineer in Pittsfield, Massachusetts

Job Purpose Quality Representative in product development projects which focuses on validation and production of implantable and non-implantable plastic medical devices and supporting equipment's . Responsible for creating and maintaining measurement programs in Zeiss and other inspection equipment , visual and dimensional inspection of all products according to customer requirements and inspection records. Skills / Qualifications Bachelor's Degree in engineering preferred, minimum high school diploma or equivalent. 2-5 years' related experience and/or training , or equivalent combination of education and/ or experience in quality engineering in the medical industry. Strong Computer skills; Microsoft Office ( Word, Excel) and Minitab Must have a strong attention to details Leadership skills and team player Highly organized 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. Physical Requirements Must be able to lift up to 25 lbs. Must be able to sit or stand for long periods of time Must be able to climb up and down stairs Other Special Requirements Support cross functional teams and departments as required Travel is required to support company initiatives Perform job duties in accordance to ISO 13485/9001 including ISO audits Safety Responsibilities Ensure that all safety procedures are followed Ensure that all equipment safeties are not altered or defeated. Direct Reports None Duties and Responsibilities Proficient in GD&T and metrology. Able to read detailed blueprints. Work with Design /tooling engineer in building mechanical gages for easy of inspections. Develop inspection programs, instructions and inspection report for QA inspectors. Train QA inspectors/ Lead QA inspectors / Quality Engineer to program Investigate and implement ease of reporting inspection data and analysis automatically from inspection equipment. Perform dimensional and visual inspection (dimensions such as length, height, contamination and distance) using precision instruments such as micrometers, calipers, dial indicator, Micro Vu and CMM to ensure product meets specifications and documents inspection results by completing reports and logs 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 equipments 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 Project Manager, QA Manager and customers on validation activities progress. Key Participant of weekly meetings with Project Manager, QA Manager, Manufacturing and Process 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. Perform other duties as assigned

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