Working at Freudenberg: We will wow your world!<h1>Responsibilities:</h1><ul><li>Understand quality system requirements to support the development, qualification and manufacturing of products to meet internal and external requirements.</li><li>Utilize statistical analysis tools to support project team.</li><li>Support creation of Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, and all quality related documentation.</li><li>Assist in and may lead supporting nonconformances, complaints, CAPAs, etc. to resolve quality issues.</li><li>Support internal and external audits, ensuring quality system compliance.</li><li>Support Measurement System Analysis (MSA), including Gage R&amp;R, test method validations.</li></ul><h1>Qualifications:</h1><ul><li>Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.  </li><li>0-3 years’ experience in Medical Device or a related regulated industry.</li><li>Knowledge 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>Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.  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).  </li><li>Familiarity with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria. </li></ul>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 Ireland Ltd.

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.

Associate QA Engineer (Validation)

Working at Freudenberg: We will wow your world!<h1>Responsibilities:</h1><ul><li>Understand quality system requirements to support the development, qualification and manufacturing of products to meet internal and external requirements.</li><li>Utilize statistical analysis tools to support project team.</li><li>Support creation of Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, and all quality related documentation.</li><li>Assist in and may lead supporting nonconformances, complaints, CAPAs, etc. to resolve quality issues.</li><li>Support internal and external audits, ensuring quality system compliance.</li><li>Support Measurement System Analysis (MSA), including Gage R&amp;R, test method validations.</li></ul><h1>Qualifications:</h1><ul><li>Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.  </li><li>0-3 years’ experience in Medical Device or a related regulated industry.</li><li>Knowledge 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>Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.  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).  </li><li>Familiarity with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria. </li></ul>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 Ireland Ltd.

Associate QA Engineer (Validation)

About the Job

About the Company

Freudenberg

Similar Jobs

Quality Engineer

Quality Engineer

Quality Engineer

Quality Engineer

Engineer - Verification and Test

Engineer - Verification and Test

Product Quality Engineer - Low Voltage Systems

Product Quality Engineer - Low Voltage Systems

Quality Assurance Engineer

Quality Assurance Engineer

Quality Engineer

Quality Engineer

Quality Engineer

Quality Engineer

Quality Systems Engineer

Quality Systems Engineer

Robotics Quality Engineer

Robotics Quality Engineer

Quality Engineer Integration (2nd Shift)

Quality Engineer Integration (2nd Shift)