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Medical Device Senior Quality Engineering Manager

Medical Device Senior Quality Engineering Manager

Canon USA’s Healthcare Optics Research Lab is collaborating with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. We are developing biomedical optical imaging and medical robotics technologies. Drive Quality excellence at our Healthcare Optics Research Laboratory for commercialization of our biomedical devices in collaboration with world-leading medical institutions. We are seeking an experienced Medical Device Senior Quality Engineering Manager (Sr Manager, Qty Engrg (HORL)) who will be responsible for leading the set up requirements for a good product, and ensure that products meet those requirements.

Establishes and builds a Quality Engineering and Validation team. Develops and designs sampling plans, performing verification and validation testing in compliance with ISO 13485 and FDA regulations, requirements and guidelines. Provides guidance on required documentation and assists with product and process improvements. Leads or drives risk management activities, including hazard analysis, FMEA's and maintains the Design History File (DHF). Works with product from design to design transfer to manufacturing, including any necessary design changes that are part of post-manufacturing or market. Acts as Quality Engineering subject matter expert for the product. Work with qualifying suppliers to determine the best option for assistance making the product or components, including what design and manufacturing criteria or specification should be used to evaluate parts and materials.

Responsibilities

  • Drive continuous improvement of the Quality Engineering and Design Assurance function, including proactive process audits, failure evaluations, root cause identification, and implementation of corrective actions
  • Manage the Supplier Quality and internal audit programs
  • Collaborate with contract vendors to integrate external processes under the HORL QMS as necessary
  • Prepare and update Quality documents and SOPs. Review and approve interdepartmental records, documents, and SOPs to ensure conformance with regulations and guidelines
  • Support the Design Control and Risk Management process as a subject matter expert
  • Provide training to cross functional groups on design assurance and risk management
  • Develop KPI’s and regular reporting methods on the same
  • Support Management review meetings
  • Engage with internal and external cross-functional teams to facilitate horizontal process improvements

Qualifications

  • 10+ years medical device experience Quality experience, including demonstrated experience in FDA/ISO environment supporting medical device commercialization of software controlled electromechanical devices as well as sterile disposable devices
  • Demonstrated experience managing a supplier quality function
  • ASQ certification as CMQ/OE is a plus
  • Six Sigma Black belt certification is an asset
  • B.S. or higher degree in a technical discipline is a requirement
  • Strong working knowledge of FDA, ISO 13485 and MDSAP requirements
  • Proficient in Microsoft Offic
  • Must possess strong oral and written communication skills
  • The company will not pursue or support visa sponsorship for this position. 

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