Insulet Corporation

Sr. Quality Design Assurance Engineer

Job Locations US-MA-Billerica | US-MA-Billerica
Posted Date 2 months ago(1/2/2018 9:52 AM)
Category
Regulatory Affairs / Clinical Affairs

Position Summary

Provides leadership and guidance for design and process changes for sustaining engineering projects. Responsible for ensuring marketed product change management processes are followed, including design controls, risk management, and verification and validation. Interface with other Insulet departments on issues related to quality.

Responsibilities

  • Participate in product changes, project reviews, and relevant project meetings
  • Ensure that design and process changes are engineered and manufactured in conformance with product requirements, required standards and regulations.
  • Review and approve design control documents and design changes
  • Support Deviations, Nonconformances, CAPA s requiring Design Assurance input/approval
  • Support change control management as subject matter expert
  • Support the QA role in product investigation meetings as required
  • Support, if needed, external audits (partner, regulatory)
  • May initiate and support Quality Management Systems (QMS) improvements within area of responsibility
  • Provide expertise, guidance and training within area of responsibility to the organization
  • Performs other duties as assigned.
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Education and Experience

  • BS degree in engineering, a technical or scientific discipline; or equivalent experience.
  • Minimum of 4 years’ experience in Quality in an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
  • Experience in the development and implementation of effective Quality Systems, particularly related to design assurance, change management, and product release.

 

 

Skills/Competencies:

  • Effective verbal and excellent technical writing skills. Ability to communicate at multiple levels of an organization.
  • Ability to organize and judge priorities.
  • Excels at generating and maintaining organized and accurate records.
  • Knowledge of Engineering principles and risk management.
  • PC skill, word processing, spreadsheet, database.
  • Able to work effectively in a high-stress, high-energy environment.
  • Able to make decisions quickly based on vague or imperfect information.

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