JOB POSITION PURPOSE

• To work with Medical Devices Facilities and other teams providing Technical management, strategic and tactical vision, and leadership to initiate, develop and implement effective quality systems and lead large scale project which result in significant business impact.
• He / She provides Quality Leadership and technical consulting on a broad range of issues to aid the business unit in setting plan and objectives, facilitate employee development and innovation to identify, develop and implement new and more effective processes.

PRINCIPAL ACTIVITIES OR RUTINARIES:

• Provides leadership for quality assurance, technical quality, quality systems development, projects and procedures which ensure effective Safety and Quality attitudes and practices
• Ensure that all elements of the corporate Human Resources Development and diversity policy are fully supported.
• Conduct Quality systems assessments identify opportunities and develop action plans on the manufacturing facilities driving the continuous improvement.
• Selects, develops, coaches and evaluates personnel to ensure the efficient operation of the function and systems development.
• Coaches and guides team members and teach specific technical knowledge to others as appropriate.
• Manage teams and self in accordance with the expected behavior and leadership qualities.
• Develops, implements, and maintains technical quality assurance and control systems activities.
• Ensures processes and systems are complaint to both internal and external requirements.
• Specifies required standards, methods, and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of the product.
• Provides leadership in the development of budgets, and evaluate personnel, objectives, strategic policies and work plan to ensure business and implemented effectively.
• Provide leadership for continuous improvement based on opportunities in different international market such Japan or Asia pacific.
• Develops and maintains strong networks the Organization with appropriate teams so that quality best practices can be developed, shared and implemented effectively.
• Responsible for representing the Management of the areas of quality assurance and quality control of the company, defining the appropriate procedures and controlling the processes, establishing the guides of systems that comply with the regulations of:

• • ISO 13485
  • GMP,
  • United States (21 CFR parts 820/210/211/11)
  • European Community (MDD93/42/EEC)
  • Canada (Canadian Medical Device Regulations SOR/98-282)
  • Brazil (ANVISA resolution RDC No.16 2013, RDC 40 2015 (Class I, II), RDC 185 2001 Class III)
  • Australia (Therapeutic goods act)
  • Japan (MHLW MO 169).
  • Mexico COFEPRIS (NOM-241-SSA1) and other applicable regulations.
  • Serve as sanitary officer as is define on the NOM-241-SSA1-2021 Good Manufacturing practices for medical devices.

REQUIRED QUALIFICATIONS:

GRADE:         Normally requires a Bachelor’s degree in a science, engineering or related discipline, an advance technical degree

ENGLISH:      Incumbent must be fully bi-lingual English-Spanish

EXPERIENCE: 8+ years industrial experience or another equivalent

                        combination of education and experience.