Manufacturing Process Quality Assurance Specialist

hace 1 día

Alajuela, Alajuela, Costa Rica Freudenberg Medical Srl. A tiempo completo

Freudenberg Medical Srl. is a global leader in medical device design and manufacturing, driving innovation through excellence in quality, lean manufacturing, and product development.

About Us:

We are a diverse team of professionals passionate about delivering high-quality products that make a difference in people's lives. With over 50,000 employees in 60 countries, we generate sales of over 10 billion euros annually.

Your Role:

As our ideal candidate, you will be responsible for ensuring the quality of all in-house manufactured parts, facilitating problem-solving for defects, and providing expertise in manufacturing processes control. You will also coordinate development activities with Manufacturing and Engineering to help them in process qualifications and drive closure on improvement actions.

Key Responsibilities:

  • Audit and ensure manufacturing processes are in place to produce reliable products in a repeatable manner.
  • Conduct process audits and drive closure on improvement actions.
  • Cordainate all aspects of 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.
  • 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.

Requirements:

  • 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.
  • Excellent organizational, communications and project management skills and the ability to work effectively in a multi-task environment.
  • 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.

What We Offer:

  • An estimated annual salary of $75,000 - $90,000, depending on your level of experience and qualifications.
  • A comprehensive benefits package, including health insurance, meal allowance, diversity & inclusion programs, training/career development, and sustainability/community service opportunities.

How to Apply:

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