Grove Technical Resources, INC
Sr Quality Engineer – Medical Device
Grove Technical Resources, INC, Danvers, Massachusetts, us, 01923
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.
Responsibilities
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.
Qualifications
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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering, Design, and Manufacturing
Industries
Medical Practices, Medical Equipment Manufacturing, and Software Development
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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.
Responsibilities
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.
Qualifications
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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering, Design, and Manufacturing
Industries
Medical Practices, Medical Equipment Manufacturing, and Software Development
#J-18808-Ljbffr