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Supplier Quality Engineer-III/ Quality Engineer/Supplier Engineer

Company: Infotree Service Inc
Location: raynham
Posted on: May 3, 2021

Job Description:

Company DescriptionPharmaceutical/Medical DeviceJob DescriptionThe Supplier Quality Engineer III will provide complex support of steady state manufacturing processes. This individual will utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO). The Supplier Quality Engineer III will address and correct product and process complaints. He/she will report on contract manufacturer performance metrics and management reviews. This individual will oversee audits of all quality system categories to assess compliance to process excellence standards. The Supplier Quality Engineer III will ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management. He/she will handle complex technical issues for manufacturing processes that are to be transferred to satellite facilities. This individual will provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.QualificationsQualificationsA minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred. A minimum of 4 years of experience in a GMP and/or ISO regulated industry is required. Experience in the medical device and/or pharmaceutical industry is preferred. Operations supplier quality experience is preferred. Both, FDA and ISO regulations knowledge is required. FDA CFR Part 820 and/or ISO 13485 knowledge is preferred. Strong communication, teamwork, and problem solving skills are required. Strong root cause analysis skills are required. Experience or knowledge with machining manufacturing processes and injection molding is preferred. Six Sigma, Lean, or ASQ Certification and/or trainings are preferred. This position will be based in Warsaw, IN (preferred) or Raynham, MA and require up to 25% travel, including possible international travel.Additional InformationAll your information will be kept confidential according to EEO guidelines.Job Location

Keywords: Infotree Service Inc, Brockton , Supplier Quality Engineer-III/ Quality Engineer/Supplier Engineer, Other , raynham, Massachusetts

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