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Development Quality Engineer II

Westford, MA 01886

Posted: 01/30/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 534953 Is job remote?: No Country: United States

Job Description

Target PR: $48-58 commensurate on experience

Exempt/Non Exempt: non exempt

Years Experience: 2-5

Skills: Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills

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

  • 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, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues
  • 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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