Development Quality Engineer in Plymouth, MN at Volt

Date Posted: 5/22/2020

Job Snapshot

Job Description

Development Quality Engineer (6-month contract)
Plymouth, MN

Volt has partnered with a growing manufacturing company in search of a Development Quality Engineer!

Responsibilities:

  • Participate in or lead teams in supporting quality disciplines, decisions, and practices.
  • Lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects.
  • Generation of PDP design verification test plans/reports for product/system requirements.
  • Lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments.
  • Lead identification of essential outputs and generate Essential Output reports.
  • Completion of labeling verification activities and labeling verification reports.
  • Work with design engineering in the completion of customer/system/product requirements.
  • Work with design engineering in the completion of product verification and validation.
  • DHF content completion, integrity and regulatory & standards compliance.
  • Collaborate communication resolving gaps.
  • Complete document change request reviews in a timely and objective manner.
  • Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.

Requirements:

  • Bachelor level degree in an Engineering Discipline or other technical field experience.
  • 1-3 years of engineering experience.
  • Must have medical device and development Quality experience.

Volt is an Equal Opportunity Employer