Quality Assurance Specialist

hace 1 semana


Mexicali, Baja California, México North American Production Sharing A tiempo completo
Job Description

About the Role:

We are seeking a highly skilled Quality Systems Coordinator to join our team at North American Production Sharing. This is an exciting opportunity for a motivated professional to lead our quality assurance efforts and drive process improvement initiatives.

About the Position:

This role will be responsible for developing and maintaining procedures that meet quality standards, including ISO 13485 and FDA regulations. The successful candidate will work closely with cross-functional teams to identify areas for improvement and implement process changes.

Duties and Responsibilities:

  • Develop and maintain quality records, documentation, and training programs.
  • Evaluate process quality data and customer claims to identify trends and opportunities for improvement.
  • Coordinate continuous improvement efforts, including process improvement projects, internal audits, and corrective actions.
  • Collaborate with other sites to discuss quality standards and align criteria for specific customer requirements.
  • Prepare and conduct internal audits to verify effective implementation of quality procedures.
  • Participate in product or process validation to document changes and improvements within the process.
  • Support new product introduction and external audit preparation activities.
  • Train employees on quality standards fundamentals and support the development of quality systems documentation.

Requirements:

  • Bachelor's degree in engineering (industrial, bioengineering, mechanical, or related field).
  • Lean/Six Sigma Green Belt certification (Black Belt desirable).
  • Certified as a Lead Auditor by a certification company (ASQ) desirable.
  • 3-5 years of experience within the quality area and the ISO 9000 certification process.

Benefits:

  • A competitive salary range of $80,000 - $110,000 per year, depending on experience.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Ongoing training and development opportunities to enhance your skills and career prospects.

Location:

This role is based in-person in our production facility.



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