Brooksource
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Qualifications
•Bachelor’s degree in engineering or technical field with minimum of 2 years of Quality Engineering experience or advanced degree with 0 years of experience
•Corrective Action experience – specifically CAPA
•Experience with Lean Manufacturing, DMAIC problem solving experience
•Experience in Medical manufacturing and GDP practices
•Experience with internal and external audits
•Experience with Cell Operating Systems (COS)
•Agile software
•Minitab software
•The employee is also required to interact with a computer, and communicate with peers and co-workers
Responsibilities
•This role supports and oversees various products supporting Cardiovascular and Advanced Surgical Technologies.
•Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
•Collaborates with engineering and manufacturing functions to ensure quality standards are in place
•Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
•Designs or specifies 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
•Leads and/or participates in corrective/preventive action teams in resolving production and customer issues
•Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
•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
•Performs or provides guidance to Manufacturing Engineering on effective Process Validation, Test Method Validation and nonconforming material investigations
•Ensures that local quality records supporting finished devices such as Device Master Records, Device History Records, Master Validation Plans, Process FMECAs, etc..are accurate, current, and compliant to regulations
•Dispositions any materials / components that are rejected for non-conformance with thorough investigations of the cause and determination of effective corrective actions
•Identifies and implements continuous improvement ideas based on observations during day-to-day activities
•Investigates and evaluates product field problems
Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
JO-2309-139503