Quality Engineer

Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
Common Sensing
Job Ref:


New Product Development (approximately 35% of the work):

* Actively execute quality assurance in design development, including but not limited to:
* Write, review and support the development of design and development plans for new products or design changes of existing products.
* Write, review and support the development of risk management documentation, such as risk management plans, risk analysis, FMEA's, risk management report, etc.
* Writing and approving test protocols and reports.
* Executing validation and verification activities.
* Contribute to the development and maintenance of Design History Files/ Design and Development Files, as well as Technical Files. 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:
* NCR's.
* Complaints.
* Contribute to creation of Management Review records.
* Contribute to management of suppliers. Production Quality (approximately 30 % of the work):

* Actively execute quality assurance in production, including but not limited to:
* Performing quality final lot release for finished product before being released for distribution, including review of of production data from contract manufacturer.
* Support the investigation of technical problems and evaluate & implement solutions.
* Perform other acceptance activities, as required, in accordance with Common Sensing SOP-9. Expectations for team engagement:

* Proactive leadership around developing a pro-quality culture at Common Sensing.
* Actively engage with team to optimize quality related workflows.
* Actively train team and proactively provide advice around QSR.
* Report quality metrics to management on a regular basis. Expectations for external engagement:

* Interact with team members including quality and regulatory consultants.
* 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

* 2+ years of experience in a Quality role at a medical device company.
* Background/education in engineering/science or related field. Training and Skills Requirements

* Strong communication skills and experience working in small teams.
* 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 will require approximately 20% domestic and international travel.

Closing Date:
Contact Details:
Common Sensing
Contact: N/A

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