Development Quality Engineer # JN -062021-66002

Plymouth, Minnesota
Industry: Database Administrator / Engineers
Job Number: JN -062021-66002

Title:                Development Quality Engineer

Location:         Plymouth, MN 55442

Duration:        12+ Months Contract

 

Education: Bachelor level degree in an Engineering Discipline or other technical field experience

 

Duties:

  • 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
  • Accountable for 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
  • Accountable for 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, endure DHF content completion
  • Integrity and regulatory & standards compliance, collaborative 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
  • Assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues, apply sound
  • Support all company initiatives as identified by management and in support of quality management systems (QMS)
  • Environmental Management Systems (EMS) and other regulatory requirements, additional duties may be identified by functional management based on the current project/business objectives.


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