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Senior Quality Engineer

  • Anywhere

Company :
Integer Holdings Corporation

Location :
Brooklyn Park, Minnesota

Expiry Date :
Sun, 25 Apr 2021 23:59:59 GMT

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Description :
Company Overview The primary purpose of this job is to manage engineering functions. Identify and evaluate procedures and process equipment required to produce a quality product. Accountabilities & Responsibilities: – Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. – Identifies and evaluates procedures to ensure the production of quality product. – Develops new and unique approaches to complex problems and can advance technology beyond previous achieved levels. – Applies engineering concepts to resolve acute or chronic problems. – Conducts studies to understand capability for process and/or measurement systems. – Provides management with technical guidance as required. – Identifies and develops appropriate documentation for process improvement and project implementation. – Maintains liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their filed. – Develops new and unique approaches to complex problems and advance technology beyond previous company involvement. – Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs. – Provides management with technical guidance as required. – Identifies and procures the appropriate process equipment. – Investigates, develops and implements new process technologies of major scope. – Maintains liaison with individuals and business units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field. – Subject matter expert in engineering specialty/application. – Performs other duties as required. Job Requirements Minimum Education: Bachelor’s Degree in Engineering, Mathematics or Statistics required. Master’s Degree preferred. Minimum Experience: 7+ years’ experience in medical device or regulated manufacturing Specialized Knowledge: Competence in the selection and use of Quality Engineering Tools and Techniques. Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, CFR, GxP, UL, MDD, TGA etc.) Proficient in Microsoft Office and Minitab Thorough knowledge and understanding of manufacturing quality requirements and solutions to obstacles that may impact successful transition at the component, subassembly, and final assembly levels Special Skills: Ability to work independently with minimal work direction and in a cross-functional team environment. Ability to effectively communicate written and verbally. Ability to manage time effectively to ensure timely completion of tasks. Knowledge of SPC, FMEA, DOE, RCA, GDT Sound knowledge of quality management systems. Other: Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired. Recommended skills Certified Quality Engineer Certified Software Quality Engineer Certified Quality Auditor Certified Reliability Engineer Auditing Certified Bank Auditor