Master Quality Assurance Specialist

hace 2 días


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

Freudenberg Medical Srl. is a global leader in the development and manufacturing of medical devices. Our team is passionate about creating innovative solutions that improve people's lives.

About Us

We are a dynamic company with a strong focus on quality, innovation, and customer satisfaction. Our products are designed to meet the highest standards of safety and effectiveness.

Responsibilities
  • Develop and implement quality inspection procedures, test methods, and quality plans to ensure compliance with FDA regulations.
  • Coordinate and conduct qualification and validation activities for new products, processes, and test methods.
  • Prepare and review validation protocols and reports for moderate and high complexity qualifications.
  • Assess compliance with applicable regulations within the manufacturing processes and recommend improvements.
  • Investigate audit non-conformances, complaints, and Corrective and Preventive Actions (CAPA) to correct problems in the quality system or manufacturing process.
Requirements
  • Bachelor's Degree in Engineering or related science/technical field.
  • American Society for Quality CQE (Certified Quality Engineer) and/or Certified Lean Six Sigma Black Belt, preferred but not required.
  • Certified or trained as Intern Auditor.
  • Bilingual (English/Spanish) 90-100% desired.
  • At least 6 years related experience and/or training working knowledge of 21CFR820 (quality systems regulation/good manufacturing practices for medical devices), ISO 13485 and 14971 standards.
  • At least 2 years' experience leading and/or supporting NPI projects.
  • Excellent organizational, communications, and project management skills.
Benefits
  • Health insurance: comprehensive protection against health risks.
  • Occupational safety: top priority in all aspects of work.
  • Meal allowance: makes meals more affordable.
  • Diversity & Inclusion: enter a diversity-driven world of innovation.
  • Sustainability / Community service: making a difference with sustainability and community service.


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