This Job Vacancy has Expired!

Design Quality Engineer

Posted on Jul 30, 2020 by Common Sensing

Cambridge, MA 02139
Engineering
Immediate Start
Annual Salary
Full-Time

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.

Authority

  • 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

Set up alerts to get notified of new vacancies.

Similar Jobs

Design Quality Engineer

Cambridge, MA

Annual Salary