Sr Quality Engineer

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.

Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.

Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

Alajuela

On-Site

Freudenberg Medical srl.

You support our team as

Sr Quality Engineer Responsibilities

• Solves complex problems or problems where precedent does not exist and takes a new perspective on existing solutions
• Serves as a specialist or expert within own job discipline
• Contributes to products/services or process improvements or uses best practices and knowledge of internal or external business issues to improve products/services or processes
• Works independently or with minimal guidance
• Has in-depth working knowledge in own discipline and good knowledge of related disciplines
• Often leads projects or project steps within a broader project or has accountability for on-going activities or objectives
• Formally trains junior staff or acts as a resource for colleagues with less experience
• Level at which the professional career may stabilize for many years or until retirement
• Requires in-depth conceptual and practical knowledge of theories, practices and procedures in own job discipline and moderate knowledge in related job disciplines
• Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
• Acts as a resource for colleagues with less experience
• Leads smaller projects with moderate complexity and manageable risks and resource requirements
• Solves complex problems
• Takes a new perspective on existing solutions and exercises judgement based on the analysis of multiple sources of information
• Impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies
• Explains difficult or sensitive information; works to build consensus in complex situations

Qualifications

• Degree: Bachelor’s or University degree in Engineering, Chemistry, Biology, or a related science/technical discipline.
• 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.