Sr Quality Engineer

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.