Principal Quality Engineer

Location: Glendale, WI
Salary: $60.00 USD Hourly - $70.00 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.

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