Quality Engineering Manager

Location: Paramit - Corporate Headquarter
Job Code: 1193
# of openings: 1

Description

Paramit is a rapidly growing international medical device contract design and manufacturing company that designs and manufactures high-quality medical and life sciences instruments. Headquartered in Morgan Hill, CA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused culture. We are seeking a Quality Engineering Manager to join our team.

As our Quality Engineering Manager, you will develop, manage, coordinate, and evaluate the activities of the Quality Engineering function for Paramit Corporation with contract manufacturing and product development. Ensure the execution of the various manufacturing and CAPA processes are in compliance with U.S. FDA 21 CFR 820 regulations, ISO 9001, ISO 13485:2016, the EU Medical Device Regulation (EU 2017/745), and other applicable regulatory agencies.

 

Essential Duties & Core Responsibilities:

  • Ensures the Quality Management System is maintained in compliance with all applicable FDA Quality System Regulations, ISO 9001, ISO 13485:2016, the Medical Device Regulation
  • Generates Quality System performance metrics
  • Oversee Quality Engineering organization
  • Oversees the Customer Complaint processing and Corrective and Preventive Action (CAPA) Program
  • Supports internal and external audit program and activities
  • Supports Management Reviews and preparation of Quality reports
  • Implements and ensures effectiveness and compliance of the Quality Management System for the Morgan Hill Manufacturing site

 

Minimum Education & Experience Requirements:

  • Bachelor’s degree in Technology, Engineering, or equivalent, or 10 to 20 years of hands-on experience in the medical device industry comprised of at least ten years’ experience in a quality function or equivalent combination of education and experience
  • Demonstrated experience in the use of Problem Solving Techniques
  • Regulatory knowledge specific to the FDA Quality System Regulations, ISO9001/ISO13485, and the Medical Device Directive (MDD) and Medical Device Regulation required
  • Proven ability to work in a cross-functional team environment
  • Excellent interpersonal and communication skills and a high level of computer literacy
  • Experience in the manufacture of PCBAs and box builds

 

Working with Paramit, you will be at the forefront of technology and a part of making a difference in the medical device and life science instrument industries. These industries touch an immeasurable amount of people, communities, countries, and our world.

At Paramit, we are committed to excellence at every level in the organization. As a manufacturer and designer of highly complex medical devices and life science instruments, we are acutely aware of our responsibility to those who will use the products we make one day. As a result, Paramit is obsessive about doing things the right way, going beyond FDA requirements, and ensuring that every finished product is safe and reliable.





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