Job Details: Quality Assurance & Regulatory Affairs Director

Quality Assurance & Regulatory Affairs Director
Job Id:
Tijuana, Mexico
Mexico - Indexed to USD
Job Description:

Job Description:

Worldwide leader in the medical devices and pharmaceutical manufacturing industry is seeking a seasoned Quality Assurance and Regulatory Affairs Director for its operations in Tijuana, Baja California. The incumbent will have the opportunity to make a big contribution to the company as a facilitator of all quality assurance, regulatory affairs, quality systems, and quality engineering areas. This position will handle all FDA regulations and compliance.

Job Duties & Responsibilities:

  • Quality systems
  • Documentation
  • Supplier Development
  • Incoming Inspection
  • Chemical Lab
  • Calibration Department
  • QC NPI
  • Sterlization
  • Complaints Investigation
  • Quality Engineering

Canidates Specifications & Skills Required:

  • At least 10 years of experience in quality management in a medical devices/pharmaceutical industry.
  • Must have experience handling regulatory affairs, FDA, validation, ISO-13485, quality systems, quality engineering, SQA, and NPI.
  • Experience handling quality in an injectable fluids manufacturing facility is a big plus.
  • Must have experience with clean rooms, laboratory and process control.
  • Must have excellent leadership, business acumen, and team player attitude.
  • Hands-on experience applying lean/six sigma principles in a medical devices/pharmaceutical manufacturing environment.
  • BS in Biochemical Engineering or related.
  • Fluent in English and Spanish.

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