Quality Engineer

hace 2 semanas

Alajuela, Alajuela, Costa Rica Freudenberg Group A tiempo completo

Working at Freudenberg: We will wow your world

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

  • 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.

Freudenberg Medical srl.

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