Description

• Job roles and responsibilities:
• • Represent Quality on product development teams as responsible individual for ensuring compliance with company quality and applicable regulatory requirements and standards
• • Lead effort and ensure completion of Risk Management activities for new and/or modified products and processes authoring risk management plans and reports, facilitating risk assessment activities
• • Work with Program Management to integrate quality by design concepts into the design and development policies and procedures.
• • Work with Operations and R&D to develop manufacturing quality plans and set quality standards for new and/or modified products and processes to ensure a high level of product quality
• • Develop and implement traceability programs for new products and modified products.
• • Review and provide input for design verification and validation protocols and reports to ensure compliance with the quality management system
• • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures