Working at Freudenberg: We will wow your world!<h1>Responsibilities:</h1><ul><li>Site Subject Matter Expert on numerous ISO elements and champion site-wide standardization and continuous improvement initiatives. Has the ability to balance compliance with lean systems to support business.</li><li>Apply statistical tools (Minitab, Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, improve process capability, and support lean manufacturing and risk reduction initiatives.</li><li>Utilize statistical tools to support the optimization of processes.</li><li>Create and ensure project quality planning documentation, required, sampling plan, process controls, early launch activities, monitoring activities to ensure compliance with customer project requirement.</li><li>Lead and collaborate cross-functionally with engineering, operations, quality /regulatory affairs, customers and suppliers to address quality related issues.  </li><li>Ability to manage CAPA Review Board, provide working solutions that meets compliance and business needs &amp; provide summary of issues to senior management.</li><li>Lead and mentor Quality Engineers and Technicians, providing technical guidance, developing junior talent, and ensuring effective daily support for production, process improvement, and customer satisfaction.</li><li>Lead New Product Introduction (NPI) Quality Activities and design transfer activities, including design verification, process validation (IQ/OQ/PQ), risk management (FMEA), and compliance with regulatory standards.</li><li>Known by the site as the go to person to address the specific area.</li><li>Ability to use current site knowledge and support other sites helping them to address their site concerns.</li><li>Lead supplier quality activities such as supplier selection, qualification, documentation, audits, quality agreement, coordination of supplier-driven product/process changes.</li><li>Lead internal and external audits, manage external auditors, oversee internal audit program and report on quality system compliance to site leadership with recommendation for area requiring improvements.</li><li>Lead and collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to ensure all change related items are adequately assessed, documented and tested as required.</li></ul><h1>Qualifications:</h1><ul><li>Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.  </li><li>8+ years’ quality engineering experience in the medical device industry.</li><li>Understanding of statistical methods, process control, and the use of quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC, as well as GD&amp;T and fixturing.  </li><li>Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.  </li><li>Advanced understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.  </li><li>Extensive knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States, MDSAP).  </li><li>Demonstrated ability to lead internal and external audits and inspections effectively, including leading preparations and addressing findings.  </li><li>Expertise in conducting thorough root cause analyses for complex quality issues and developing effective CAPAs.  </li><li>Experience with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.</li></ul>Preferred: <ul><li>5+ years’ experience in injection molding manufacturing operations or equivalent.</li><li>Project management experience</li><li>Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC).</li><li>Lean/Six Sigma certification</li></ul>The expected salary range for this position is $95,000 to $115,000 annually, depending on skills, experience, and qualifications.‎ ‎ The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.Freudenberg Medical LLC

Freudenberg e-Power Systems is one of the world's leading suppliers of emission-neutral energy systems for heavy-duty applications. With its experience and expertise in battery and fuel cell technology, the company offers tailor-made solutions, in particular combined systems, for sustainable and economical e-mobility. With over 800 employees, Freudenberg e-Power Systems supports its customers from application development through to production, commissioning and service.
The company is part of the global Freudenberg Group, which has four business areas: Seals and Vibration Control Technology, Nonwovens and Filtration, Household Products as well as Specialties and Others. In 2022 the Group generated sales of more than 11 billion euros and employed more than 50,000 associates in around 60 countries.

Sr. Quality Engineer - Medical Manufacturing

Working at Freudenberg: We will wow your world!<h1>Responsibilities:</h1><ul><li>Site Subject Matter Expert on numerous ISO elements and champion site-wide standardization and continuous improvement initiatives. Has the ability to balance compliance with lean systems to support business.</li><li>Apply statistical tools (Minitab, Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, improve process capability, and support lean manufacturing and risk reduction initiatives.</li><li>Utilize statistical tools to support the optimization of processes.</li><li>Create and ensure project quality planning documentation, required, sampling plan, process controls, early launch activities, monitoring activities to ensure compliance with customer project requirement.</li><li>Lead and collaborate cross-functionally with engineering, operations, quality /regulatory affairs, customers and suppliers to address quality related issues.  </li><li>Ability to manage CAPA Review Board, provide working solutions that meets compliance and business needs &amp; provide summary of issues to senior management.</li><li>Lead and mentor Quality Engineers and Technicians, providing technical guidance, developing junior talent, and ensuring effective daily support for production, process improvement, and customer satisfaction.</li><li>Lead New Product Introduction (NPI) Quality Activities and design transfer activities, including design verification, process validation (IQ/OQ/PQ), risk management (FMEA), and compliance with regulatory standards.</li><li>Known by the site as the go to person to address the specific area.</li><li>Ability to use current site knowledge and support other sites helping them to address their site concerns.</li><li>Lead supplier quality activities such as supplier selection, qualification, documentation, audits, quality agreement, coordination of supplier-driven product/process changes.</li><li>Lead internal and external audits, manage external auditors, oversee internal audit program and report on quality system compliance to site leadership with recommendation for area requiring improvements.</li><li>Lead and collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to ensure all change related items are adequately assessed, documented and tested as required.</li></ul><h1>Qualifications:</h1><ul><li>Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.  </li><li>8+ years’ quality engineering experience in the medical device industry.</li><li>Understanding of statistical methods, process control, and the use of quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC, as well as GD&amp;T and fixturing.  </li><li>Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.  </li><li>Advanced understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.  </li><li>Extensive knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States, MDSAP).  </li><li>Demonstrated ability to lead internal and external audits and inspections effectively, including leading preparations and addressing findings.  </li><li>Expertise in conducting thorough root cause analyses for complex quality issues and developing effective CAPAs.  </li><li>Experience with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.</li></ul>Preferred: <ul><li>5+ years’ experience in injection molding manufacturing operations or equivalent.</li><li>Project management experience</li><li>Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC).</li><li>Lean/Six Sigma certification</li></ul>The expected salary range for this position is $95,000 to $115,000 annually, depending on skills, experience, and qualifications.‎ ‎ The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.Freudenberg Medical LLC

Sr. Quality Engineer - Medical Manufacturing

About the Job

About the Company

Freudenberg

Similar Jobs

Principal Supplier Quality Engineer

Principal Supplier Quality Engineer

Principal Quality Engineer

Principal Quality Engineer

Quality Engineer

Quality Engineer

R&D Project Quality Engineer (f/m/d)

R&D Project Quality Engineer (f/m/d)

Sr. Quality Engineer

Sr. Quality Engineer

Senior Product and Process Quality Engineer

Senior Product and Process Quality Engineer

Quality Engineer II

Quality Engineer II

Senior Quality Engineer

Senior Quality Engineer

Sr. Manufacturing Engineer

Sr. Manufacturing Engineer

Product & Supplier Quality Engineer

Product & Supplier Quality Engineer