Quality Assurance Manager for Medical Devices

hace 6 días


Mexicali, Baja California, México Medline A tiempo completo

Job Summary

We are seeking a highly experienced Quality Assurance Manager to lead our Quality department at Medline. As a key member of our team, you will be responsible for directing the development of product specifications, partnering with suppliers, and implementing quality strategies.

About Us

MEDLINE is a leading manufacturer and distributor of medical devices, committed to delivering high-quality products that meet or exceed regulatory requirements. Our company values innovation, collaboration, and customer satisfaction.

Responsibilities

  • Direct the development of product specifications for Medline branded products, including testing requirements, procedures, and methods for testing, inspecting, or qualifying new products and suppliers.
  • Partner with Supplier Audit department and Division to determine optimal Supplier relationships.
  • Develop and implement strategy for the Quality department(s) based upon Quarterly Management Review.
  • Prepare and deliver Customer presentations.
  • Act as liaison with Senior Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on-time delivery, and customer satisfaction.
  • Collaborate with Suppliers, manufacturing partners, and product managers in developing and implementing QA programs.
  • Oversee QSR for assigned department(s) and ensure compliance as measured by FDA/ISO/internal audits.
  • Management responsibilities include:
    • Typically manages through multiple Managers.
    • Provides leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability.
    • Strategic, tactical, and operational planning (12+ months) for the function or department.
    • Direct budgetary responsibility for one or more departments, functions, or major projects/programs.

Requirements

To succeed in this role, you must have:

Bachelor's degree in Engineering, Science, or Technical Field.At least 7 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).At least 4 years of management experience.

What We Offer

We offer a competitive salary of $1,000 - $2,000 MXN per month, commensurate with experience. Additionally, we provide benefits according to the LFT, and opportunities for professional growth and development.

Location

This position is located in Mexico, and requires regular travel within the country.



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