Working at Freudenberg: We will wow your world!
Responsibilities:Understand quality system requirements to support the development, qualification and manufacturing of products to meet internal and external requirements.
Utilize statistical analysis tools to support project team.
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.
Assist in and may lead supporting nonconformances, complaints, CAPAs, etc. to resolve quality issues.
Support internal and external audits, ensuring quality system compliance.
Support Measurement System Analysis (MSA), including Gage R&R, test method validations.
Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
0-3 years’ experience in Medical Device or a related regulated industry.
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&T and fixturing.
Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
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).
Familiarity with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.
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 LLCSkills Required
- Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical field.
- 0-3 years' experience in Medical Device or a related regulated industry.
- Knowledge of statistical methods, process control, and statistical analysis tools.
- Experience with quality tools: Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC.
- Experience with GD&T and fixturing.
- Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
- Understanding of ISO standards (ISO 13485, ISO 14001, ISO 14971) and GMP principles.
- Knowledge of country-specific regulatory requirements (e.g., 21 CFR 820).
- Familiarity with design control, validation protocols, and creation/support of Master Validation Plans (IQ/OQ/PQ).
Freudenberg Group Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Freudenberg Group and has not been reviewed or approved by Freudenberg Group.
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Healthcare Strength — Healthcare is considered strong at many U.S. sites, with low‑cost options, HSA contributions, and on‑site clinics in some locations.
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Retirement Support — A 401(k) with company match is standard across U.S. entities, though exact match mechanics differ by business group and year.
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Leave & Time Off Breadth — Paid time off is often described as good, with some locations offering generous holiday schedules.
Freudenberg Group Insights
What We Do
Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with its partners, customers and research institutions, the Freudenberg Group develops leading-edge technologies and excellent products and services for about 40 markets and for thousands of applications: seals, vibration control components, technical textiles, filters, specialty chemicals, medical products and the most modern cleaning products. Strength of innovation, strong customer orientation, diversity, and team spirit are the cornerstones of the Group. The 170-year-old company holds strong to its core values: a commitment to excellence, reliability and pro-active, responsible action. In 2022, the Freudenberg Group employed more than 51,000 people in some 60 countries worldwide and generated sales of more than €11.7 billion. Learn more about us and visit our digital home at freudenberg.com and read the stories that make us Freudenberg. Visit and follow us at www.freudenberg.com https://www.instagram.com/freudenberg.group/ www.youtube.com/FreudenbergGroup www.facebook.com/freudenberggroup *** Netiquette *** We look forward to receiving your comments and posts. On behalf of all users, we ask for constructive contributions, mutual respect, courtesy and tolerance. All contributions will be checked and we reserve the right to delete contributions. This applies in particular to unlawful content, incorrect statements, advertising for third parties, spam or slander. In addition, we reserve the right to remove comments that are otherwise inappropriate or incorrect. Contributions made by external users do not necessarily reflect Freudenberg’s opinion. Please find our data protect information here: https://www.freudenberg.com/fileadmin/downloads/english/2020-11_DataProtectionInformation_SocialMedia_EN.pdf
