Quality Engineer (Projects)

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.Some of your Benefits Cafeteria/ Canteen: We offer fresh food on-site, both hot and cold.Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.Health Insurance: Rely on comprehensive services whenever you need it.On-site Medical Service: Our on-site medical service can handle a variety of medical needs.Meal Allowance: We offer an allowance that makes meals more affordable. AlajuelaOn-Site Freudenberg Medical srl.You support our team as Quality Engineer (Projects) Responsibilities Serve as the Quality representative on cross-functional project teams for new product introduction (NPI), product updates, and manufacturing transfers.Ensure compliance with applicable standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, MDR) throughout the product lifecycle.Lead and support verification & validation (V&V), risk management (ISO 14971), and product transfers as per Customer requirements and FMCR Quality Management System.Review and approve document change orders (DCRs), device master records (DMRs), technical documentation and validation protocols and reports.Collaborate with Customers, Manufacturing, Engineering and Supply Chain to drive quality in all phases of development.Participate in risk assessments (FMEAs) and ensure risk controls are implemented and verified.Support CAPA (Corrective and Preventive Action) investigations and nonconformance resolution related to project activities.Contribute to supplier quality activities, including qualification and validation of suppliers and components.Support validation of manufacturing processes, equipment, and test methods (IQ/TMV/OQ/PQ).Create and develop Quality Inspection plans, Control plans, Quality Inspection procedures as per Customer requirements.Assist in internal and external audits as needed (e.g., Customer Audits, FDA, Notified Body).Drive continuous improvement of quality systems and processes.Qualifications Bachelor’s Degree in Engineering (Mechanical, Biomedical, Electrical, or related field) or equivalent technical discipline.5–7 years of experience in a Quality Engineering role, with at least 3 years in the medical device industry.Strong knowledge of FDA QSR, ISO 13485, and ISO 14971.Experience with design controls, product development processes, and risk management.Familiarity with validation principles (IQ, OQ, PQ) and statistical tools (e.g., Minitab, JMP).Strong technical writing, documentation, and communication skills.Ability to work independently and within a team in a fast-paced, regulated environment.Certified Quality Engineer (CQE) or Six Sigma certification.Experience with EU MDR, ISO 10993, IEC 60601, or software-related standards (IEC 62304).Experience with electronic quality management systems (eQMS) such as MasterControl, and SAP.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.