Sr Quality Engineer

Sr Quality Engineer Katalyst Healthcares & Life Sciences - 4.0 Danvers, MA Job Details Contract 10 hours ago Qualifications Developing medical devices New product introduction Content creation for technical audiences Technical documentation ISO standards Quality control statistical data analysis Technical writing within manufacturing Statistical analysis Production validation processes Quality risk management Design failure mode and effects analysis (DFMEA) Regulatory/legal compliance standards in production Engineering product development Biomedical regulatory compliance Test validation method FDA regulations

Full Job Description Job Description:

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:

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. Able to present quality 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 to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.

Requirements:

Medical Device Design & Development.

Risk Management:

dFMEA, pFMEA, Statistical analysis.

Technical Writing:

IQs, PQs, TMVs. Hands on experience on upstream new product development vs 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, risk management. Green Belt Six Sigma/DRM Training/Certification is preferred, but not required. ASQ-CQE, CQA, CBA or equivalent certifications preferred, but not required. SAP QM or SPC Software experience preferred, but not required. 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.