Associate QA Engineer (Validation)
Responsibilities
- Learn and apply quality system requirements to support the development, validation, and manufacture of life-changing medical devices.
- Use statistical tools and data analysis to support project teams and build strong problem-solving skills.
- Support the creation of validation documentation, including Master Validation Plans and IQ/OQ/PQ protocols and reports.
- Contribute to risk management activities, design reviews, and core quality documentation.
- Assist with investigations into nonconformances, complaints, and CAPAs, helping to drive real improvements.
- Support internal and external audits and learn how quality systems operate in a regulated environment.
- Take part in Measurement System Analysis (MSA), including Gage R&R and test method validations.
- Work closely with cross-functional teams and gain exposure across engineering, manufacturing, and R&D.
Qualifications
- Bachelor’s degree in Engineering, Chemistry, Biology, or a related technical/scientific discipline.
- 0-3 years’ experience in medical devices or another regulated industry (graduates welcome).
- Basic knowledge of quality and statistical tools such as DOE, FMEA, Control Plans, MSA, SPC, and GD&T.
- A curious mindset with strong problem-solving, analytical, and critical-thinking skills.
- Understanding of ISO standards (ISO 13485, ISO 14001, ISO 14971) or a willingness to learn.
- Awareness of GMP principles and regulatory requirements (e.g., 21 CFR 820).
- Interest in design control, validation, and verification processes.
- A proactive attitude and desire to build a long-term career in Quality at Freudenberg Medical.
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.
