Quality Engineer I

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.

Compensation

for this position will be determined by the candidate's qualifications, experience, education, and overall alignment with the role's responsibilities. ‎ ‎ 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