Quality Engineer I
- Location
- Beverly, MA
- Listed
- Today
About the role
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.
Qualifications
- 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.
Additional information
Compensation for this position will be determined by the candidate's qualifications, experience, education, and overall alignment with the role's responsibilities.
Freudenberg Medical LLC
Equal opportunity and legal notices
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.
From Freudenberg's careers page, first listed on Rolev.ai on November 10, 2026. Rolev.ai is not the employer.
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All Quality Engineer jobsCommon questions
Where is the Quality Engineer I job at Freudenberg located?
This Quality Engineer I position at Freudenberg is located in Beverly, MA. Always check Freudenberg's application page for specific state eligibility or relocation policies.
How do I apply for the Quality Engineer I position at Freudenberg?
This listing links directly to Freudenberg's Workday application page. You can apply directly on Freudenberg's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Workday application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.