IPG PHOTONICS CORPORATION

Quality Assurance Manager

General Information
Location  377 Simarano Drive
Suite 302
Marlborough, MA 01752
United States
Employee Type  Exempt FT (I)
Job Category  Manufacturing
Description

Description:

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Quality Manager is responsible for maintenance and continuing improvement of the quality management system (QMS) and compliance with all applicable regulations and standards for medical devices.

Duties:

  • Responsible, under general direction of Senior Management,  for reviewing, improving and maintaining most aspects of the quality system including the Quality Manual and procedures/processes, including document and data control, quality planning, training, vendor approval / monitoring, equipment calibration, complaint handling and trending, product recalls / advisory notices, corrective and preventive action system, internal quality audits, non-conforming materials, incoming and final inspection
  • Reporting on the performance of the quality management and proposing recommendations to improve the system to Senior Management
  • Support, as needed, regulatory assurance, engineering and Senior Management with regulatory filings, creation of technical files, vigilance / incident reports, internal and external audits, and sign-off for relevant documents
  • Conduct product design control activities for new and sustaining product development efforts
  • Support risk analysis activities, including design and process FMEA
  • Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities
  • Support Manufacturing Engineering in the creation of DMR, DHR, routers, bills of material, and specifications for in- house / external manufacturing
  • Conduct Internal Audits of the Quality System
  • Prepare for and participate in audits by external organizations, such as FDA, ISO etc.
  • Perform all other essential duties as assigned

 

 
Requirements

 

Experience Desired:

  • 10-15 years of experience in Medical Device Quality Assurance, with a minimum 5 years of hands-on management experience is required
  • Solid understanding of  applicable regulations, including  FDA  21 CFR Part 820, ISO 13485, Health Canada MDD’s, European MDR’s
  • Experience with Medical Device start-ups is a plus

 

Education Required:

  • Bachelor’s degree in scientific, biomedical, or engineering discipline required

 

Personal Requirements:

  • Self-motivated and proactive, with consistent ability to follow-through on projects
  • Impeccable attention to detail
  • Strong oral, written and interpersonal skills required for interaction within the organizations and external customers
  • Hands-on and results-oriented, with ability to multitask
  • Ability to maintain professional demeanor at all times

 

This position must meet Export Control compliance requirements, therefore a “US Person” as defined by 22C.F.R. §120.15 are required. “US Person” includes US Citizen, lawful permanent resident, refugee, asylee.   License exception Technology and software under restriction (TSR) defined in 15 CFR 740.6 may permit person from Country Group B.

The following link will take you to the government site with the list of Country Group B: https://www.bis.doc.gov/index.php/documents/regulation-docs/452-supplement-no-1-to-part-740-country-groups/file