Principal Quality Engineer

Location: Newton, MA
Salary: $90.00 USD Hourly - $100.00 USD Hourly
Description: Our client is currently seeking a Principal Quality Engineer for a 6 month + contract.

Job Title: Principal Quality Engineer, Contractor

Location: Endovascular Robotics business within Advanced Therapies

Employment Type: Full-time

Shift: 1st shift; 9-5, flexible for core hours (10-4)

Screening: Background and drug screening required

About Us: We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance, and dedicated devices will revolutionize neurovascular procedures, enabling better outcomes and improving access to care.

Responsibilities:

• Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices.
• Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products and production equipment.
• Develop test plans, inspect, and assess material compliance based on dimensional and attribute acceptance criteria, while documenting and communicating inspection results.
• Determine optimal measurement devices to perform inspections. Understand AQL tables and select the correct sampling rate based on quality criteria.
• Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
• Utilize quality tools including Risk analysis FMEA, statistical techniques such as six-sigma and DOE (design of experiments), root cause analysis, reading and correcting drawings.
• Lead the development and implementation of visual and physical inspections of injection molded, mechanical, electrical, and packaging components to ensure they meet specifications.
• Assist Quality Engineers and manufacturing personnel with calibration activities, including reviewing and retrieving calibrated equipment necessary for processing.
• Manage Root Cause Analysis activities stemming from MRB, RMA, and CAPA.
• Analyze/trend non-conformances through NCMRs and RMAs.
• Assist in supplier audits and visits, as required.
• Assist in the manufacturing transfer process including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).
• Support other duties as assigned by the manager.

Required Knowledge/Skills, Education, and Experience:

• Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
• Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical devices.
• Experience with new product development.
• Working knowledge of QSR, MDD/MDR, ISO-13485, and ISO-14971.
• Experience in metrology.
• Strong organizational skills, detail-oriented, and the ability to meet changing deadlines in a fast-moving environment.
• Strong documentation capability for protocol and report generation and review.
• Ability to communicate effectively within a technical environment.
• Team player who celebrates winning together.
• No travel required.

By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.

Contact:

This job and many more are available through The Judge Group. Please apply with us today!