Planet Pharma
Sr Quality Engineer at Planet Pharma
The Senior Quality Engineer position supports new product development for Surgical Instruments. In this role, you will work as part of the quality team supporting the cross-functional core team. An understanding of mechanical and electromechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred. You will provide guidance and implement strategies that drive product quality and continuous improvement. Responsibilities
Actively participate in 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, complaint analysis, etc. 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. Embedded Responsibilities: Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills. Qualifications
Education Required : 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 in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality. Years Of Experience : 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 Or Experience : Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both 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; ability to work well under pressure and maintain a positive, enthusiastic attitude Strong attention to detail and accuracy. Ability to balance and prioritize multiple ongoing projects/tasks (Project Management skills) High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning NICE TO HAVE
ASQ Certified Quality Engineer (CQE) Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements Understanding of software and hardware interface The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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The Senior Quality Engineer position supports new product development for Surgical Instruments. In this role, you will work as part of the quality team supporting the cross-functional core team. An understanding of mechanical and electromechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred. You will provide guidance and implement strategies that drive product quality and continuous improvement. Responsibilities
Actively participate in 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, complaint analysis, etc. 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. Embedded Responsibilities: Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills. Qualifications
Education Required : 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 in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality. Years Of Experience : 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 Or Experience : Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both 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; ability to work well under pressure and maintain a positive, enthusiastic attitude Strong attention to detail and accuracy. Ability to balance and prioritize multiple ongoing projects/tasks (Project Management skills) High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning NICE TO HAVE
ASQ Certified Quality Engineer (CQE) Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements Understanding of software and hardware interface The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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