Quality Engineer I

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high‑quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings. Benefits 401K Match: Save for retirement with the company's help. Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees. Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success. Personal Development: We offer a variety of trainings to ensure you can develop in your career. Corporate Events: We celebrate success as a team, because only together we can achieve our goals. *Candidates must be legally authorized to work in the United States without current or future visa sponsorship* We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time‑off. Beverly, MA – On‑Site – Freudenberg Medical LLC Payments: The expected salary range for this position is $65,000 to $75,000 annually, depending on skills, experience, and qualifications. Quality Engineer I Responsibilities Performs all measures of quality planning for incoming and in‑process inspections as well as final acceptance – develop and support generation of flow charts, FMEAs and control plans. Handles multiple projects and tasks, from product inception through product launch and maintenance. Plays an active role in processes to ensure products meet quality standards consistent with internal quality policy. Supports plant activities in process validation, process capability issues and customer issues, initiates corrective and preventive action with an eye to increased capability, reduced inspection time/effort, customer satisfaction and supports Quality System implementation. Transitions products from development to manufacturing by composing and/or reviewing protocols and reports for the IQ/OQ/PQ process. Establishes statistical standards of performance by providing support and expertise in Gage R&R, DOE, reliability strategy, and analytical problem‑solving techniques. Establishes manufacturing inspection, sampling and statistical process control methods and procedures to assure the quality of manufactured products. Assures compliance to in‑house and external specifications and standards, such as GMPs, GDPs, ANSI and ISO regulations. Supports customer and ISO audits for assigned projects and supports internal audit programs as an auditor. Identifies and highlights any problem issues associated with quality. Provides input for solutions to problems identified. Performs/leads with the investigation of root cause and determination of corrective and preventive actions relating to NCMRs and CAPAs. Interfaces with manufacturing and engineering to resolve quality issues for new and existing product lines. Helps control the nonconforming product/MRB process. Drafts reports, work instructions, and other technical documents. Upholds company mission and values through accountability, innovation, integrity, quality, and teamwork. Supports the schedule and day‑to‑day tasks for the quality department to ensure internal and external needs are met in a timely manner. Provides training to in‑house personnel regarding instructions and standards of work. Trains inspection personnel on entries and record utilization, measurement equipment, SAP, best quality practices, etc. Participates and supports in safety and lean/continuous improvement initiatives. Qualifications Bachelor's degree in Engineering or related field. Minimum of 3 years of experience as a Quality Engineer. Minimum of 3 years of experience in a manufacturing environment of medical or health‑care products and knowledge of injection molding processes. Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) preferred. Lean/Six Sigma certification preferred. Project management experience preferred. Experience with ERP systems such as SAP preferred. 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. #J-18808-Ljbffr