Sr Quality Engineer – Medical Device

Overview

Job Title: Sr Quality Engineer – Medical Device

Job Location: Danvers, Massachusetts (Fully Onsite)

Type: W2 Contract

Duration: 6 Months

Job Description: Technical skills that are required for the role include Medical Device Design & Development;

Risk Management:

dFMEA, pFMEA, Statistical analysis;
Technical Writing: IQs, PQs, TMVs; and 5 years of experience.

• Provide Quality Engineering support for commercial medical device products.
• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished materials products.
• 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.

• 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
  • 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, and risk management.

• Mid-Senior level

• Contract

• Engineering, Design, and Manufacturing

• Medical Practices, Medical Equipment Manufacturing, and Software Development