Quality Engineering Manager

IPG Photonics•Marlborough, MA

About The Position

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Quality Engineering Manager is responsible for managing the quality engineering activities for transfer to manufacturing and sustaining manufacturing in compliance with all applicable regulations and standards for medical devices.

Requirements

Minimum of a bachelor’s degree in science, engineering, or other related technical discipline and 5 – 10 years of medical device experience or 10-15 years of experience in medical device quality engineering.
Solid understanding of medical device ISO 13485, FDA 21 CFR 820.
Familiar with MDR (EU) 2017/745/MDD, ISO 14971
Experience with intravascular catheters and/or electro-mechanical hardware.
Able to effectively manage workload and deliverables.

Nice To Haves

Medical device software experience a plus.
Experience with sterile product preferred.

Responsibilities

Provide manufacturing quality engineering leadership to manufacturing and sustaining engineering.
Manage direct reports by providing direction, mentorship and growth opportunities
Report on the Manufacturing and Quality KPIs
Conduct product design control activities for new and sustaining product development efforts
Support risk analysis activities, including design and process FMEA
Participate in quality driven supply chain activities.
Participate in the reliability / customer complaint team meetings.
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
Prepare for and participate in internal and external audits with notified bodies and customers
Perform other duties as assigned to support the advancement of the QMS and product manufacturing.