Quality Engineer

Quality Engineer Location: Foothill Ranch, CA Amplify Surgical has an immediate opening for a Quality Engineer. Job Overview The Quality Engineer will support the implementation, maintenance, and continuous improvement of the company’s Quality Management System (QMS) and product quality activities. This position will work cross-functionally with Operations, Engineering, Supply Chain, Customer Service, and other departments to ensure products and processes meet established quality, regulatory, and business requirements. The position requires strong technical, organizational, and interpersonal skills and the ability to independently execute quality activities in a fast-paced medical device environment. Responsibilities include document and change control, supplier quality, nonconforming material, CAPA, complaints, inspection activities, validation, risk management, and maintenance of quality records. Responsibilities Quality System & Document Control Support the routing, review, approval, release, and control of Quality Management System documents and records. Review Document Change Requests (DCRs) and Engineering Change Orders/Requests for completeness, technical impact, validation requirements, risk considerations, and compliance with established procedures. Evaluate proposed changes to determine potential impact to product quality, manufacturing processes, inspection requirements, specifications, risk management documentation, and other controlled documents. Support maintenance and continuous improvement of procedures, work instructions, forms, specifications, and other QMS documentation. Assign, monitor, and maintain employee training records associated with controlled documents and procedures. Support maintenance of Device Master Records (DMRs), Design History Files (DHFs), and other applicable quality records. Validation & Process Qualification Review and support validation and qualification activities for manufacturing processes, equipment, inspection methods, software, and other quality-critical processes. Develop, review, and/or execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports. Review validation documentation to ensure acceptance criteria, sampling methods, test methods, results, deviations, and conclusions are appropriately documented and technically justified. Support development and execution of process validations, test method validations, and other qualification activities as required. Assess manufacturing and process changes to determine whether new validation, revalidation, or additional verification activities are required. Support investigation and documentation of validation deviations and implementation of appropriate corrective actions. Risk Management Develop, review, and maintain Process Failure Mode and Effects Analyses (PFMEAs) and other applicable risk management documentation. Participate in risk assessments associated with product, process, supplier, and manufacturing changes. Ensure identified process risks and risk controls are appropriately reflected in manufacturing procedures, inspection requirements, validation activities, and quality documentation. Support updates to risk management documentation resulting from CAPAs, nonconformances, complaints, process changes, or other post-market information. Supplier Quality & Approved Supplier List (ASL) Maintain supplier qualification and approval status within the Approved Supplier List. Support supplier qualification, monitoring, re-evaluation, and supplier corrective action activities. Participate in supplier audits and maintenance of the supplier audit program. Review supplier quality documentation, certifications, inspection results, and other records as required. Investigate supplier-related quality issues and work with suppliers and internal stakeholders to implement appropriate corrective actions. Nonconforming Material, CAPA & Complaints Support the identifica…

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