Develop, modify, implement, and maintain quality standards and protocols for the transformation of materials into finished or partially finished products.
Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
Design 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 analyses to assess the cost and determine liability for products or materials that do not meet required standards and specifications.
Lead and/or participate in corrective/preventive action teams to resolve production and customer-related issues. Ensures that corrective actions meet acceptable reliability standards and that documentation complies with requirements.
May specialize in the areas of design, incoming materials, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
Perform or provide advice to manufacturing engineering on effective process validation, test method validation, and nonconforming material investigations. Ensure that local quality records for finished devices, such as device master records, device history records, baseline validation plans, process Failure Modes, Effects, and Criticality Analysis (FMECAs), etc., are accurate, up-to-date, and compliant with regulations.
Dispose of all materials/components rejected due to nonconformity by conducting a thorough root cause investigation and determining effective corrective actions. Identifies and implements continuous improvement ideas based on observations made during daily activities.
Reviews and evaluates product issues in the field.
Qualifications
Bachelor's degree in engineering or a technical field with a minimum of 2 years of experience in quality engineering, or a graduate degree with 0 years of experience.
