Job Title: Principal Quality Engineer

Job Description

We are seeking an ambitious Principal Quality Engineer in the greater Boston area.

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 and understand AQL tables to 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, 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.

Essential Skills

• Experience with New Product Development.
• Design Quality Engineering.
• Validation Protocols.
• FMEA Risk analysis.
• Supplier quality management.
• Electric 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.
• Working knowledge of QSR, MDD/MDR, ISO standards.
• Experience in metrology.
• Strong organizational skills, detail-oriented, and ability to meet changing deadlines.
• Strong documentation capability for protocol and report generation and review.
• Ability to communicate effectively within a technical environment.

Work Environment

This position is based in an office/lab environment and operates during the 1st shift from 9 AM to 5 PM with flexibility for core hours between 10 AM and 4 PM. The role does not require travel and involves background and drug screening.