Quality Engineer Sustaining

Quality Engineer / Senior Quality Engineer in Carlsbad, CA

We're a Fortune 500 company and leading manufacturer of orthodontic medical devices, seeking an experienced Quality Engineer to join our team! We provide innovative products, services, and solutions to help practitioners deliver exceptional care to their patients, while concurrently building successful practices. In the USA, our products are marketed to orthodontic practitioners through a strong direct sales force, and internationally, our products are sold in more than 85 countries through 160+ distributors.

The Quality Engineer is responsible to develop and implement systems to ensure products or services are designed and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD/MDR and others as required.

Quality Engineer job responsibilities:

• Participate in the implementation of improvements to the company's quality management system procedures including Nonconformance Material processes, Customer Complaint handling, Supplier Management, process validation, Measurement Systems Analysis and other quality engineering duties.
• Responsible to perform and may help mentor others in performing thorough Root Cause Analysis, Corrective Action planning and implementation and Verification of Effectiveness planning and implementation; Corrective Action process will apply to internal nonconformities, product complaints, supplier quality issues, and will also provide engineering analysis and support in verification, validation and problem solving.
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes. Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations.
• Drives supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis. Partners with key suppliers and manufacturing personnel to reduce defects and improve yield. Participates in supplier selection and qualification processes, including supplier quality audits.
• Develops processes for the effective generation of metrics, including established Key Process Indicators, for use within the Quality Department.
• Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements. Implements problem solving methodologies to reduce internal and external defects.
• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects. Ensures validation of key design inputs including usability, reliability, performance, manufacturability, safety and effectiveness.
• Plan, control and assure product and process quality in accordance with quality principles and best practices, including process planning, material control, acceptance sampling, measurement systems and process validation. Identifies and implements product and process controls consistent with the outcome of the risk management process.
• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Regulation, US FDA, MDSAP and others as required.
• Supports computer system validation and stays current with validation regulatory requirements.
• Participates in special projects and perform other duties as required.

Qualifications:

• Bachelor's Degree with 4+ or more years of increasing responsibility in terms of any applicable professional experience.
• Strong working knowledge of medical device regulations including ISO 13485:2016, 21CFR820, MDR and other global regulatory requirements.
• Demonstrated success in the implementation of problem-solving methods and tools.
• Understanding of the effective implementation of the entire risk management process, including the identification and implementation of appropriate controls in product development and/or operations.
• Experience in product verification/validation, process validation and test system development and implementation. Experience in the development and implementation of processes and testing meant to satisfy quality and regulatory standards in the medical device industry, as well as drive product and process quality.
• Practical experience with the implementation of statistical tools and techniques.
• Past experience in developing appropriate trending related to operational and product quality. Previous success in driving improvement through root cause analysis and CAPA projects.
• Strong understanding of best practices related to supplier quality and supplier development.
• General knowledgeable in computer system validation and related regulatory requirements.