Freudenberg Group

Global group manufacturing seals, cleaning, textiles

Senior Quality Engineer

Quality EngineeringConfirmed live in the last 24 hours

Full-timeAlajuela Province, Alajuela, Costa RicaNo salary listedIn-person

About the Job

Requirements

A bachelor's or university degree in Engineering, Chemistry, Biology, or a related science/technical discipline is required.
Five to eight or more years of quality engineering experience within the medical device or regulated manufacturing industry are required.
Proficiency in Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), Measurement Systems Analysis (MSA), Control Plans, and Geometric Dimensioning and Tolerancing (GD&T) is required.
Strong knowledge of Good Manufacturing Practices (GMP) and global standards including ISO 13485, ISO 14001, and ISO 14971 is required.
Familiarity with FDA regulations such as 21 CFR Part 820 and the Medical Device Single Audit Program (MDSAP) is required.
Expertise in root cause analysis and implementing Corrective and Preventive Actions (CAPA) is required.
Ability to lead internal and external regulatory audits and inspections is required.
Bilingual proficiency in English and Spanish is generally expected for roles based in Alajuela, Costa Rica.

Responsibilities

Solve complex problems, including problems without precedent, and apply new perspectives to existing solutions.
Serve as a specialist or expert within the job discipline.
Contribute to product, service, and process improvements by applying best practices and knowledge of business issues.
Work independently or with minimal guidance.
Apply in-depth knowledge of the job discipline and related disciplines.
Lead projects or project steps within broader projects and maintain accountability for ongoing activities or objectives.
Formally train junior staff and act as a resource for less experienced colleagues.
Lead smaller projects with moderate complexity, manageable risks, and resource requirements.
Exercise judgment based on analysis of multiple information sources and explain difficult or sensitive information to build consensus in complex situations.
Influence customer, operational, project, or service activities within own and related teams while working within broad guidelines and policies.

Working at Freudenberg: We will wow your world!

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).

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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.

About the Company

Freudenberg Group

Global group manufacturing seals, cleaning, textiles

Freudenberg Group is a German family-owned technology company with a diversified portfolio across seals, consumer cleaning products, technical textiles, and filtration. It develops and sells high-tech components and sealing systems for automotive and industrial use, as well as consumer brands like Vileda, O-Cedar, and Wettex, and provides nonwovens and filtration solutions for automotive, construction, and medical applications. It stays different from competitors through family ownership and broad diversification across markets and products, which reduces dependence on any single cycle. Its goal is to grow by offering a wide, globally distributed range of technically informed products while preserving long-term ownership and stability through diversification.

Company size: 10,001+
Company stage: Not listed
Total funding: Not listed
Headquarters: Weinheim, Germany
Founded: 1849

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