Product Quality Engineer
3 weeks ago
Title: Sr. Product Quality Engineer Location: Atlanta, GA 30313 Duration: 12 Months Shift: 8AM to 5PM Description: The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success. This individual will be leading and managing a risk management team but could also work on other items. Looking for someone well rounded from a development quality perspective. Responsibilities: Lead and/or support on-time completion of Design Control deliverables Support the establishment of objective, measurable, and verifiable product requirements Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities Lead Risk Management activities from product concept through commercialization Support test method development and lead test method validation activities Support manufacturing process development & qualification for new product and design changes Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications Support biocompatibility and sterilization qualifications Support audits and quality system improvement activities Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements. Comply with client, U.S. FDA, EUMDR and other requirements, as applicable. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers. Basic Qualifications: Bachelors degree in Engineering or Technical Field. Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development. Experience in medical devices and associated regulations/standards. Experience in test method development and validation Experience in preparing risk assessments, FMEA and other risk documents. Preferred Qualifications: Advanced Degree in Engineering/Technical Field Experience in active implantable medical devices. Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA). Working knowledge of statistics and its application to verification and validation.
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Quality Engineer Medical Device
3 weeks ago
Atlanta, GA, United States Rook Quality Systems Full timeOur consulting firm is experiencing rapid growth and we are looking for additional quality engineers to support our medical device clients. We help innovative medical device companies around the world design, document, manufacture, and sell their medical device products. We pride ourselves on providing the best, most efficient, and effective medical device...
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Quality Engineer Medical Device
3 weeks ago
Atlanta, GA, United States Rook Quality Systems Full timeOur consulting firm is experiencing rapid growth and we are looking for additional quality engineers to support our medical device clients. We help innovative medical device companies around the world design, document, manufacture, and sell their medical device products. We pride ourselves on providing the best, most efficient, and effective medical device...
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Quality Engineer Medical Device
3 weeks ago
Atlanta, GA, United States Rook Quality Systems Full timeOur consulting firm is experiencing rapid growth and we are looking for additional quality engineers to support our medical device clients. We help innovative medical device companies around the world design, document, manufacture, and sell their medical device products. Ready to apply Before you do, make sure to read all the details pertaining to this job...
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Atlanta, United States Rook Quality Systems Full timeOur consulting firm is experiencing rapid growth and we are looking for additional quality engineers to support our medical device clients. We help innovative medical device companies around the world design, document, manufacture, and sell their medical device products.We pride ourselves on providing the best, most efficient, and effective medical device...
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Quality Engineer Medical Device
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Atlanta, United States Rook Quality Systems Full timeBase pay range$70,000.00/yr - $90,000.00/yrOur consulting firm is experiencing rapid growth and we are looking for additional quality engineers to support our medical device clients. We help innovative medical device companies around the world design, document, manufacture, and sell their medical device products.We pride ourselves on providing the best, most...
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