Sr Quality Engineer

Posted 3 Days Ago
Be an Early Applicant
Alajuela, Alajuela, CRI
In-Office
Senior level
Other • Automation • Manufacturing
The Role
Senior Quality Engineer responsible for solving complex quality problems, improving products and processes, leading projects, training junior staff, and supporting regulatory compliance. Requires extensive medical device or regulated manufacturing experience, expertise in quality engineering tools, GMP and ISO standards, FDA and MDSAP requirements, root cause analysis, CAPA, and internal and external audits. English-Spanish bilingual proficiency is generally expected for Costa Rica-based roles.
Summary Generated by Built In

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).

    ‎ ‎

    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.

    Skills Required

    • Bachelor's or university degree in Engineering, Chemistry, Biology, or a related science or technical discipline
    • 5 to 8+ years of quality engineering experience in the medical device or regulated manufacturing industry
    • Proficiency in Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, Measurement Systems Analysis, Control Plans, and GD&T
    • Strong knowledge of Good Manufacturing Practices, ISO 13485, ISO 14001, and ISO 14971
    • Familiarity with FDA 21 CFR Part 820 and MDSAP
    • Expertise in root cause analysis and implementation of Corrective and Preventive Actions
    • Ability to lead internal and external regulatory audits and inspections
    • Bilingual proficiency in English and Spanish for Costa Rica-based roles

    Freudenberg Group Compensation & Benefits Highlights

    The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Freudenberg Group and has not been reviewed or approved by Freudenberg Group.

    • Healthcare Strength Healthcare is considered strong at many U.S. sites, with low‑cost options, HSA contributions, and on‑site clinics in some locations.
    • Retirement Support A 401(k) with company match is standard across U.S. entities, though exact match mechanics differ by business group and year.
    • Leave & Time Off Breadth Paid time off is often described as good, with some locations offering generous holiday schedules.

    Freudenberg Group Insights

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    The Company
    HQ: Weinheim
    17,448 Employees

    What We Do

    Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with its partners, customers and research institutions, the Freudenberg Group develops leading-edge technologies and excellent products and services for about 40 markets and for thousands of applications: seals, vibration control components, technical textiles, filters, specialty chemicals, medical products and the most modern cleaning products. Strength of innovation, strong customer orientation, diversity, and team spirit are the cornerstones of the Group. The 170-year-old company holds strong to its core values: a commitment to excellence, reliability and pro-active, responsible action. In 2022, the Freudenberg Group employed more than 51,000 people in some 60 countries worldwide and generated sales of more than €11.7 billion. Learn more about us and visit our digital home at freudenberg.com and read the stories that make us Freudenberg.​ Visit and follow us at www.freudenberg.com https://www.instagram.com/freudenberg.group/ www.youtube.com/FreudenbergGroup www.facebook.com/freudenberggroup *** Netiquette *** We look forward to receiving your comments and posts. On behalf of all users, we ask for constructive contributions, mutual respect, courtesy and tolerance. All contributions will be checked and we reserve the right to delete contributions. This applies in particular to unlawful content, incorrect statements, advertising for third parties, spam or slander. In addition, we reserve the right to remove comments that are otherwise inappropriate or incorrect. Contributions made by external users do not necessarily reflect Freudenberg’s opinion. Please find our data protect information here: https://www.freudenberg.com/fileadmin/downloads/english/2020-11_DataProtectionInformation_SocialMedia_EN.pdf

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