About this Sr Quality Engineer role at Freudenberg Group
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.