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Design Quality Engineer

Posted on Jul 30, 2020 by Common Sensing

Cambridge, MA 02139
Immediate Start
Annual Salary

Must be authorized to work in the US. Unfortunately, sponsorship is not available.

Responsible for:

  • New Product Development (approximately 35% of the work):
    • Actively execute quality assurance in design development, including but not limited to:
      • Support writing and/ or updating design and development plans for new products or design changes of existing products.
      • Support writing and/or approving risk management documentation, such as risk management plans, risk analysis, FMEA's, risk management report, etc.
      • Support writing and/or approving test protocols and reports.
      • Support writing and/ or approving test method validations such as Gauge R&R and Attribute Agreement Analysis.
      • Support writing and/ or approving equipment qualification protocols and reports.
      • Support executing validation and verification activities.
      • Support creating and/ or maintaining Design History Files/ Design and Development Files, as well as Technical Files.
      • Support reviewing and/ or approving design output documentation.
  • Quality Management System (approximately 35% of the work):
    • Ensure that quality system requirements are effectively maintained in compliance with FDA 21 CFR Part 820 and ISO 13485:2016.
    • Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
    • Contribute to the achievement of the quality objectives.
    • Participating in Common Sensing's QMS audits.
    • Execution and record generation of key QMS process, including but not limited to:
      • NCRs.
      • Complaints.
      • CAPA.
      • Contribute to the creation of Management Review records.
      • Contribute to the management of suppliers.
    • Maintain company training documentation.
    • Coordinate equipment calibration and maintain related records.
    • Maintain the approved supplier list (ASL) and supplier files.
  • Production Quality (approximately 30 % of the work):
    • Actively execute quality assurance in production, including but not limited to:
      • Performing quality final lot release for the finished product before being released for distribution, including review of production data from a contract manufacturer.
      • Support the investigation of technical problems and evaluate & implement solutions.
      • Support developing and/ or updating component and supplier controls.
      • Support developing and/ or updating critical to quality specifications, in-process tests/inspection, or final process specifications.
      • Participate and contribute to the material review board.
      • Perform other acceptance activities, as required, in accordance with Common Sensing SOP-9.
      • Actively participate in the interactions with the contract manufacturer and suppliers as it related to Quality and provide support in the resolution of quality problems.

Expectations for team engagement:

  • Engage team in day to day activities, especially related to design and development activities, to contribute to project tasks.
  • Ability to work with different small teams and take directions from related project leads.

Expectations for external engagement:

  • Support communications with notified bodies and regulatory agencies.
  • Support communications with Common Sensing partners as it relates to Quality.


  • Represent Common Sensing Quality Department to internal customers and external customers.
  • Reporting on the performance and effectiveness of the quality system and any need for improvement to Quality Department management for review.

Education, Experience, and Background Requirements

  • B.S. degree in an Engineering or related technical discipline.
  • 4+ years of experience working in either Quality or Product Development at a medical device company.
  • Experience with the following is desired. Equivalent education, skills, or experience will be also be considered:
    • Design controls, including transfer to manufacturing, per FDA 21 CFR Part 820 and ISO 13485:2016.
    • Creating and/ or reviewing design verification and process validation plans, protocols, and reports.
    • Creating and/ or reviewing equipment qualification protocols and reports.
  • Demonstrated ability to manage multiple tasks and priorities simultaneously and adapt to changes in program priorities.

Training and Skills Requirements

  • Ability to effectively communicate both orally and in writing.
  • High level of attention to details.
  • Relevant Quality related certifications (E.g. ASQ CQE) or equivalent experience.
  • Training in all Common Sensing's QMS processes.
  • Ability to work with small teams and external suppliers & customers.
  • This position is located in Cambridge, MA, and may require approximately 10-20% domestic and international travel.
  • Remote work is allowed for the duration of the pandemic. In-office work will be expected when the office re-opens.

Reference: 918727396

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