Sr Quality Engineer
Katalyst CRO · Danvers, MA · 2 mo ago
HybridQuality AssuranceContract
Responsibilities
- Provide Quality Engineering support for commercial medical device products.
- Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Able to present quality during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation.
- Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis.
Requirements
- MEDICAL DEVICE DESIGN & DEVELOPMENT.
- RISK MANAGEMENT: dFMEA, pFMEA, STATISTICAL ANALYSIS.
- Techical Writing: IQs, PQs, TMVs.
- HANDS ON EXPERIENCE ON UPSTREAM NEW PRODUCT DEVELOPMENT VS DOWNSTREAM MANUFACTURING TRANSFER AND OPERATIONS QUALITY.
- WORKING KNOWLEDGE OF QUALITY SYSTEM REGULATION (QSR 21 CFR 820), CANADIAN MEDICAL DEVICE REGULATION (CMDR), EU MEDICAL DEVICE DIRECTIVE (EU MDD 93/42 EEC), JPAL, AND ISO 13485:2016.
- Demonstrated WORKING KNOWLEDGE OF PROCESS VALIDATION, STATISTICAL METHODS, RISK MANAGEMENT.
- GREEN BELT SIX SIGMA/DRM TRAINING/CERTIFICATION IS PREFERRED, BUT NOT REQUIRED.
- ASQ-CQE, CQA, CBA OR EQUIVALENT CERTIFICATIONS PREFERRED, BUT NOT REQUIRED.
- SAP QM OR SPC SOFTWARE EXPERIENCE PREFERRED, BUT NOT REQUIRED.
- BACHELOR'S DEGREE IN ENGINEERING, SCIENCE OR TECHNICAL FIELD AND 5-7 YEARS OF WORK EXPERIENCE IN ENGINEERING AND/OR QUALITY OR ADVANCED DEGREE IN ENGINEERING, SCIENCE OR TECHNICAL FIELD AND 2 YEARS OF WORK EXPERIENCE IN ENGINEERING AND/OR QUALITY.