Development Quality Engineer II

3 weeks ago

Westford, United States Intellectt Inc Full time

Role: Development Quality Engineer II

Location: Westford, MA - 01886

Duration: 06 Months on W2

Description:

Experience: 2to5years

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

Duties:

  • Participate in or lead teams to support quality disciplines, decisions, and practices.
  • Ensure on-time completion of design control deliverables.
  • Support timely execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP), and design change projects.
  • Generate PDP design verification test plans/reports for product/system requirements.
  • Lead or support Risk Management activities from product concept through commercialization, including generating risk management plans/reports, hazard analysis, FMEA, and Cybersecurity risk assessments.
  • Lead identification of essential outputs and generate Essential Output reports.
  • Ensure completion of labeling verification activities and labeling verification reports.
  • Collaborate with design engineering on customer/system/product requirements completion.
  • Collaborate with design engineering on product verification and validation.
  • Ensure Design History File (DHF) content completion, integrity, and regulatory & standards compliance.
  • Review document change requests objectively and in a timely manner.
  • Implement effective process control systems to support product development, qualification, and manufacturing.
  • Assist in implementing assurances, process controls, and CAPA systems to meet internal and external requirements.
  • Support tech development and execution of streamlined business systems to resolve quality issues.
  • Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Support company initiatives related to quality management systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
  • Additional duties may be assigned by functional management based on project/business objectives.

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