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Alajuela, Costa Rica
Onsite
Working at Freudenberg: We will wow your world!
Experience: 5 to 8+ years of quality engineering experience within the medical device or regulated manufacturing industry.
Quality Tools: Proficiency in Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), Measurement Systems Analysis (MSA), Control Plans, and GD&T.
Standards & Regulations: Strong knowledge of Good Manufacturing Practices (GMP) and global standards such as ISO 13485 (quality management), ISO 14001 (environmental), and ISO 14971 (risk management).
Regulatory Compliance: Familiarity with FDA regulations like 21 CFR Part 820 and MDSAP (Medical Device Single Audit Program).
Problem Solving: Demonstrated expertise in root cause analysis and implementing Corrective and Preventive Actions (CAPA).
Auditing: Ability to lead internal and external regulatory audits and inspections.
Language Skills: Bilingual proficiency in English and Spanish is generally expected for roles based in Costa Rica (Alajuela).
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.