Sr Quality Engineer - Exempt

Senior Quality Engineer

In this exciting role, you will have responsibility 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. This is an onsite role at the Danvers, MA location.

• 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 the 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 technical data to groups within and outside the organization.
• Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis, reading and correcting drawings.

• Bachelor's Degree in Engineering, Science or technical field AND 4 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
• Master's degree
• Manufacturing Experience
• Green Belt Six Sigma/DRM Training/Certification
• ASQ-CQE, CQA, CBA or equivalent certifications
• SAP QM or SPC Software Experience
• Effective verbal and written communication, analytical, influencing and interpersonal skills
• 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

• Medical Device Design & Development
• Risk Management:
  
  dFMEA, pFMEA, Statistical analysis
• Technical Writing: IQs, PQs, TMVs

• Education Required:
  
  Bachelor's Degree in Engineering, Science or technical field AND 4 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
• Years' Experience
  
  Required:
  
  4 years
• Work Schedule:
  
  40 hours per week
• Work Location:
  
  4 Days Onsite, 1 day remote (subject to change depending on project requirements)
• Interview Timeline:
  As soon as possible
• Product Line Supported:
  Cardiovascular, Neurovascular, Peripheral Devices