Quality Engineer

hace 5 días

Alajuela, Costa Rica Freudenberg Medical Srl. A tiempo completo

Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations.
Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments.
The Freudenberg Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world.
We are a global provider for medical device design and manufacturing with more than 2,000 employees.
Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies.
Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career.
Come join us and together we can make a difference in the future of healthcare.
**Responsibilities**:

- Ability to facilitate problem solving for defects that occur during manufacturing.
- Provides expertise in manufacturing processes control for extrusion and injection molding components.
- Audits and ensures manufacturing processes are in place to produce reliable products in a repeatable manner.
- Conduct process audits and drive closure on improvement actions.
- Coordinates development activities with Manufacturing and Engineering to help them in the process qualifications.
- Coordinate all aspects of in-process inspections within cell(s), in-process inspections within cell(s), including training for long-term support of Six Sigma initiatives and compliance to ISO 13485, 14971, QSR, 21 CFR 820 and any other applicable standard or regulation.
- Responsible for the Quality of all in-house manufactured parts.
- Evaluate and determine disposition of non-conforming materials and formulate corrective actions.
- Identify opportunities to improve manufacturing processes, e.g., lean techniques and optimized scale up.
- Technical support of customers ensuring quality standards are understood, transferred appropriately and executed.
- Internal coordination/liaison with engineering team to ensure appropriate control and introduction of any proposed changes to products and systems.
- Provide process and quality support for manufacturing, validations, process improvement and productivity activities of new

**Qualifications**:

- Deep Knowledge in Molding and Extrusion processes
- 1-3 years related experience and/or training working knowledge of 21CFR820 (quality systems regulation/good manufacturing practices for medical devices), ISO 13485 and 14971 standards.
- Requires excellent organizational, communications and project management skills and the ability to work effectively in a multi-task environment.
Projects manage tactical day to day activities along with higher level projects.
Understanding and technical leadership and guidance with statistical techniques (i.e.
sample size determination, DOE, Lean and Six Sigma process improvement techniques, etc.)
- Knowledge and understanding of quality requirements for the medical device industry with general technical understanding of business operations.
- Excellent verbal, written, analytical, computer and interpersonal skills with the ability to demonstrate lead capabilities with team approach, and sound decision making.
- Organizational, prioritization, and presentation skills required.
- Excellent interpersonal, communication, influencing, and facilitation skills.
- Ability to work effectively cross functionally.
- Bachelor's Degree in Engineering, or related science/technical field.
- Physical Demands
- Bilingual (English / Spanish) 90-100% desired.
Your Benefits

Health insurance: Insurance: backstop protection against health risks

Meal allowance: Allowance makes meals more affordable

Diversity & Inclusion: Enter a diversity-driven world of innovation

Training / Career development: Programs to supercharge skills and expertise

Sustainability / Community service: Making a difference with sustainability, community service

Additional Information

Roy Vargas
999999
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