Sr Quality Engineer - Exempt

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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. This is an onsite role at the Danvers, MA location. 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 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 years of work experience in Engineering and/or Quality OR
Advanced Degree in Engineering, Science or technical field AND years of work experience in Engineering and/or Quality.
Nice to Have: Preferred Qualifications Medical Device
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 CFR ), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD / EEC), JPAL, and ISO :
Demonstrated working knowledge of process validation, statistical methods, risk management
A Day in the Life Will the contractor be working hours a week? Yes, hours per week. Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Days Onsite, day remote (subject to change depending on project requirements). What is your timeline for scheduling interviews? As soon as possible. What product line will this person support? Cardiovascular, Neurovascular, Peripheral Devices.
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Location:
Danvers

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