Job Details: Quality Assurance & Regulatory Affairs Director

Title:
Quality Assurance & Regulatory Affairs Director
Job Id:
6557
Location:
Tijuana, Mexico
Payroll:
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.


Before applying for a job opening, please make sure we have your updated resume on file.
If we don't please upload your most recent resume first.
Only candidates who meet all required criteria will be considered.


Login to Apply for Job(s)