Sr Quality Engineer - Exempt

Join our team in Danvers, MA, a thriving hub for innovation and excellence. As a Senior Quality Engineer, you will play a critical role in ensuring the quality and reliability of our cutting-edge medical devices. This is an exciting opportunity to work onsite in a dynamic environment, collaborating with top professionals in the field.

Responsibilities Include:

• 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 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.

Must Have: Minimum Qualifications

• 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.

Nice to Have: Preferred Qualifications

• Medical Device experience
• 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