Senior Quality Control Specialist

hace 2 semanas


Ciudad de México, Ciudad de México Snaphunt A tiempo completo

About the Role

We are seeking an experienced Senior Quality Control Specialist to join our team at Snaphunt. This is a challenging and rewarding opportunity for someone who wants to drive quality and excellence in a dynamic environment.

Job Overview

  • This is a leadership role that requires strong analytical skills, attention to detail, and excellent communication skills.

Responsibilities

  • Ensure compliance with Good Manufacturing Practices (GMP) and ISO 13485 & 9001 regulations.
  • Improve the quality of outputs through continuous improvement of operations.
  • Enhance customer satisfaction by providing accurate and value-added responses to customer concerns and issues in a timely manner.
  • Drive adherence to acceptable processes and ensure strong process quality.
  • Manage a team of 6-10 people.
  • Read, verify, and modify engineering drawings as needed.
  • Design review documentation.
  • A thorough knowledge of PDP process.
  • Complaint handling.
  • Expert understanding and follow-through of CAPA process.
  • FMEA requirements and documentation.
  • OSHA certification.
  • Internal audits.
  • Leading FDA audits.
  • Serve as management representative.
  • Identify the root causes of faults or problems by conducting Root Cause Analysis.
  • Inspect and test various parts manufacturing, products, components, and compare with predefined standards.
  • Improve written procedures as needed.
  • Enhance operational controls for each process.

Requirements

  • You have at least 7 years of experience, including solid experience in a similar role within Industrial and Medical device.
  • You have working knowledge of FDA regulatory compliance.
  • You pay strong attention to detail and deliver work that is of a high standard.
  • You possess strong analytical skills, are comfortable dealing with numerical data and technical writing.
  • You are a strong mentor who builds high-performing teams, supports growth and profitability.
  • You are willing to travel once per month.

The Employer

Our client is a world-class manufacturer of medical devices and spinal orthopedic devices. With a mindset driven toward innovation, they are committed to excellence.

Salary

We offer a competitive salary range of $100,000 - $140,000 per year, depending on experience and qualifications.



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