Staff Quality Engineer

Job Type:
Perm
Sector:
IT leadership
Location:
USA
Salary:
$150k – $160k
Ref #:
A000847

**New Permanent Role – Staff Quality Engineer**

Location – Massachusetts – United States
Salary $155k - $160k Benefits Package
Industry – Medical Device

 

 

My client is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe.

 

Responsibilities:

 

  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
  • Review, and approve design control deliverables such as requirements, specifications, validation protocols and reports to ensure compliance to customer and regulatory requirements.
  • Review and approve human factors documentation such as use specifications, task analysis, formative and summative studies protocols and reports.
  • Support Risk Management activities (RMP, HA, DFMEA, PFMEA, UFMEA and RMR).
  • Support safety assurance case creation in compliance with the regulatory requirements.
  • Provides guidance to the cross-functional development team(s) in the approach to design control documentation.
  • Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
  • Support design test and inspection method development, and lead method validation activities
  • Responsible for establishing, communicating, and mitigating risk throughout the product development process
  • Participate in design reviews
  • Performs other related duties and responsibilities, on occasion, as assigned

 

Experience and Education:

  • B.S. degree in a scientific, technical, or engineering discipline.
  • 5+ Years of experience in design controls and risk management
  • Comprehensive knowledge of Quality System standards and regulations, including 21 CFR 803 & 820, ISO 13485 and ISO 14971
  • Must possess excellent oral and written communication skills, and the ability to communicate appropriately with cross-functional teams
  • Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter
  • Ability to manage and prioritise multiple activities with varying business, compliance and customer drivers.
  • Must be able to work independently and as a cross-functional team member to multi-task and do what it takes to meet high expectations and tight deadlines. I will be working on prominent projects in high-pressure situations.

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