Overview
On Site
Compensation information provided in the description
Full Time
Skills
Mergers and Acquisitions
Cross-functional Team
Testing
Test Plans
INSPECT
Regulatory Compliance
Inspection
Design Controls
Statistics
Quality Assurance
Risk Analysis
FMEA
Six Sigma
Design Of Experiments
ROOT
Electrical Engineering
Management
Root Cause Analysis
MRB
RMA
Corrective And Preventive Action
Auditing
Manufacturing
DMR
IQ
OQ
PQ
Biomedical Engineering
Life Sciences
Medical Devices
Mechanical Engineering
Product Development
ISO 13485
ISO 9000
Metrology
Organizational Skills
Attention To Detail
Documentation
Reporting
Privacy
Marketing
Job Details
Location: Newton, MA
Salary: $70.00 USD Hourly - $100.00 USD Hourly
Description:
Job Title: Principal Quality Engineer
Location: MA
Duration:- 12 + Months
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's 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 how 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 to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case 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, which includes reviewing and retrieving calibrated equipment necessary for processing Managing Root Cause Analysis activities stemming from MRB, RMA, and CAPA. Analyzing/trending 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 manager.
Required Knowledge/Skills, Education, and Experience Bachelor's degree required 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 is required. Experience with new product development required. Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required. Experience in metrology required. Strong organizational skills, detail oriented, and the ability to meet changing deadlines on 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!
Salary: $70.00 USD Hourly - $100.00 USD Hourly
Description:
Job Title: Principal Quality Engineer
Location: MA
Duration:- 12 + Months
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's 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 how 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 to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case 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, which includes reviewing and retrieving calibrated equipment necessary for processing Managing Root Cause Analysis activities stemming from MRB, RMA, and CAPA. Analyzing/trending 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 manager.
Required Knowledge/Skills, Education, and Experience Bachelor's degree required 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 is required. Experience with new product development required. Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required. Experience in metrology required. Strong organizational skills, detail oriented, and the ability to meet changing deadlines on 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!
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