Quality Engineer

hace 10 horas

Alajuela, Alajuela, Costa Rica Freudenberg Medical A tiempo completo

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.

Alajuela

On-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.
  • Review and approve document change orders (DCRs), device master records (DMRs), technical documentation and validation protocols and reports.
  • 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).
  • Assist in internal and external audits as needed (e.g., Customer Audits, FDA, Notified Body).

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).
  • Certified Quality Engineer (CQE) or Six Sigma certification.
  • 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.

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