Quality Assurance Manager

Location: Paramit - Corporate Headquarter
Job Code: 1217
# 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 seasoned Quality Assurance Manager to join our team!

As our ideal QA Manager, you are a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. 

You develop, manage, coordinate, and evaluate the activities of the Quality Assurance function (Inspection) for Paramit Manufacturing. Ensuring the execution of the various inspections, 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 are the core of you and your team's work.

 

Essential Responsibilities and Job Duties:

  • 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 inspection performance metrics
  • Oversee and manage the Quality Assurance (Inspectors) organization. Ensure adequacy of resources, training compliance, and work output/quality.
  • Oversees the in-process and final inspection functions.
  • Supports internal and external audit programs and activities.
  • Supports Management Reviews and preparation of Quality reports.
  • Ensures the continued compliance of inspection activities to the Quality Management System Requirements for the Morgan Hill Manufacturing site.
  • Ensures inspectors are certified to the appropriate standards (IPC 610, IPC 7711/21).
  • Oversee the daily spot check program and manages the “Stop on Defect” program.

 

Minimum Experience and Education Requirements:

  • Bachelor’s degree in Technology or Engineering or equivalent, or 5 to 15 years experience in the medical device industry; a minimum of ten years experience in 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
  • Preferred: Experience in the manufacture of PCBAs and box builds
  • Previous supervisory/management of inspectors; this role has a large team of direct and second-level reports working across two shifts
  • IPC 610 certification and training

 

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 one day use the products we make. 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.





Are you a returning applicant?

Previous Applicants:

If you do not remember your password click here.

Back to Search Results

New Search


Powered By Taleo