5 staff quality engineer jobs at 3 companies in Mashpee, MA
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Staff Quality Engineer
Princeton or Mansfield
$109k-$150k/yrOnsiteFull Time
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
5+ YOEBachelor's degree with 10+ years, master's with 8+ years, or doctorate with 5+ years in engineering or quality; medical device or pharmaceutical experience, process validation, IQ/OQ/PQ, data analytics, and regulatory knowledge required.
IQ/OQ/PQ, FDA, ISO 13485, ISO 9001, CMDR, MDR, 21 CFR Part 11, cGMP
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
Provide quality leadership for medical device software projects, lead requirements and risk assessments, define test strategies, manage defects, support regulatory filings and audits.
SAP Product Lifecycle Management, Scripting Languages, Model-Based Systems Engineering (MBSE)
Princeton or Plainsboro or Braintree or Chicago or Columbia
$109k-$150k/yrOnsiteFull Time
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
8+ YOEBachelor's in science/engineering, 8+ years in quality/process/R&D engineering for medical devices (3+ years direct DQA), expertise in risk management and design control, statistical analysis, MS Office and statistical software, FDA/ISO audit experience.
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
Provide software quality leadership for medical device products; lead risk assessments, define test strategies, manage verification and defects, support regulatory filings and audits, and mentor junior engineers.
SAP Product Lifecycle Management, Scripting Languages