Sr. Quality Engineer-Medical Device Design & Development

Sr. Quality Engineer (6 month contract // Danvers, MA):

4 Days Onsite, 1 day remote (subject to increase to 5 days/week depending on project requirements)

Top 3 Required Skills:

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

Education and Experience 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 exp

A Day in the Life
In this exciting role as a Senior Quality Engineer, 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.

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; 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.
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 case analysis, reading and correcting drawings.

Nice to Have:
Demonstrated working knowledge of process validation, test method validation, statistical methods, and risk management
Experience developing/improving manufacturing inspection methods
Master s degree
Green Belt Six Sigma/DRM Training/Certification
ASQ-CQE, CQA, CBA or equivalent certifications
SAP QM or SPC Software (Minitab, JMP) Experience
Effective verbal and written communication, analytical, influential, 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