Design 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:

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.
* 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.

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

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