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Sr Quality Engineer

Katalyst Healthcares & Life Sciences

Danvers, MA

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JOB DETAILS
SKILLS
American Society for Quality (ASQ), Certified Quality Engineer (CQE), Change Control, Code of Federal Regulations, Cost Analysis, Design Failure Mode and Effects Analysis (DFMEA), Digital Rights Management (DRM), Experiment Design, Failure Mode and Effects Analysis (FMEA), ISO (International Organization for Standardization), Industry Standards, Inventory Management, Maintain Compliance, Manufacturing, Manufacturing Operations, Medical Equipment, Medical Office Administration, Medical Products, Procedure Implementation, Process Failure Mode and Effects Analysis (PFMEA), Process Quality, Process Validation, Product Development, Product Lifecycle, Product Testing, Product/Service Launch, Production Control, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk Analysis, Risk Management, Root Cause Analysis, SAP, Six Sigma, Six Sigma Green Belt, Statistics, Support Documentation, System Validation, Technical Presentation, Technical Writing, Testing, United States Department of Energy (DOE), Validation Testing, Writing Skills
LOCATION
Danvers, MA
POSTED
30+ days ago
Job Summary:
  • Senior Quality Engineer responsible for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.
  • The role involves applying quality engineering principles across design, manufacturing, and product lifecycles while ensuring compliance with global regulatory standards.

Roles & 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; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • May specialize in areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
  • Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
  • Present quality aspects during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation.
  • Present technical data to groups within and outside the organization.
  • Utilize quality tools including risk analysis (FMEA), statistical techniques including Six Sigma and DOE (Design of Experiments), root cause analysis, and reading and correcting drawings.

Education & Experience:
  • 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.
  • Medical Device Design & Development experience.
  • Risk Management experience including dFMEA, pFMEA, and statistical analysis.
  • Technical writing experience including IQs, PQs, TMVs.
  • Hands-on experience in upstream new product development and 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, and risk management.
  • Green Belt Six Sigma/DRM Training/Certification preferred.
  • ASQ-CQE, CQA, CBA or equivalent certifications preferred.
  • SAP QM or SPC software experience preferred .

About the Company

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Katalyst Healthcares & Life Sciences

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