Grove Technical Resources, INC
Sr Quality Engineer – Medical Device
Grove Technical Resources, INC, North Haven, Connecticut, us, 06473
Overview
Sr Quality Engineer – Medical Device. Location: North Haven, Connecticut (Fully onsite). Type: W2 contract. Responsibilities
Actively participate in the product development cycle by reviewing mechanical/electromechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. Assess overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart. Collect, analyze, and interpret statistical data. Perform analyses and provide reports to management as required. Contribute to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses, and Process Capability Analyses. Assist with projects and assure proper and consistent implementation of quality engineering tools. Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. Demonstrate excellent organizational and communication skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail-oriented. Show problem-solving and analytical abilities; maintain a positive, proactive attitude in a fast-paced environment. Education and Experience
B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality. Preferred: M.S. degree with 4+ years of work experience in engineering or Quality. Nice to Have: 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline). Specialized Skills
Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving, and qualifying the design to ensure sustainable manufacturing of medical devices (internal and external). Experience in a regulated industry. Experience with Minitab or similar statistical analysis tools. Experience with Risk Management Tools. Good interpersonal skills; ability to work effectively in a team environment and build strong working relationships. Ability to work in a fast-paced environment; maintain a positive, enthusiastic attitude under pressure. Strong attention to detail and accuracy; ability to balance and prioritize with a high degree of initiative and self-motivation. Strong analytical skills. Nice to Have
ASQ Certified Quality Engineer (CQE) Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 13485, 14971, and 60601 requirements. Understanding of software and hardware interface. Seniority
Mid-Senior level Employment type
Contract Job functions
Engineering, Education, and Manufacturing Industries
Medical Equipment Manufacturing, Medical Practices, and Biotechnology Research
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Sr Quality Engineer – Medical Device. Location: North Haven, Connecticut (Fully onsite). Type: W2 contract. Responsibilities
Actively participate in the product development cycle by reviewing mechanical/electromechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. Assess overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart. Collect, analyze, and interpret statistical data. Perform analyses and provide reports to management as required. Contribute to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses, and Process Capability Analyses. Assist with projects and assure proper and consistent implementation of quality engineering tools. Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. Demonstrate excellent organizational and communication skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail-oriented. Show problem-solving and analytical abilities; maintain a positive, proactive attitude in a fast-paced environment. Education and Experience
B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality. Preferred: M.S. degree with 4+ years of work experience in engineering or Quality. Nice to Have: 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline). Specialized Skills
Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving, and qualifying the design to ensure sustainable manufacturing of medical devices (internal and external). Experience in a regulated industry. Experience with Minitab or similar statistical analysis tools. Experience with Risk Management Tools. Good interpersonal skills; ability to work effectively in a team environment and build strong working relationships. Ability to work in a fast-paced environment; maintain a positive, enthusiastic attitude under pressure. Strong attention to detail and accuracy; ability to balance and prioritize with a high degree of initiative and self-motivation. Strong analytical skills. Nice to Have
ASQ Certified Quality Engineer (CQE) Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 13485, 14971, and 60601 requirements. Understanding of software and hardware interface. Seniority
Mid-Senior level Employment type
Contract Job functions
Engineering, Education, and Manufacturing Industries
Medical Equipment Manufacturing, Medical Practices, and Biotechnology Research
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