Sr Quality Engineer - Exempt

Your role as a Quality Engineer in the manufacturing sector focuses exclusively on ensuring the quality and compliance of the manufacturing processes for a variety of vascular devices such as embolic coils, stents, catheters, balloons, aspiration devices, coatings, and guide wires. This position requires a deep understanding of regulatory and quality frameworks, alongside expertise in risk management, process validation, quality tools, lean manufacturing principles, CAPA, statistical analysis, and documentation, all within a manufacturing context.

Key Responsibilities

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished materials products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise 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 analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
• Troubleshoot equipment and process issues. Summarize and draw conclusions from test results leading to effective technical resolution of process problems.
• Perform detailed Root Cause Investigation of failed products or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventative actions.
• Interface with Production, Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.
• Identify, analyze, and manage risk through product life cycle with use of FMECA and other risk management tools.
• Provide training, leadership, and guidance for junior quality engineers and/or technicians.

Required Knowledge and Experience

• Minimum of 2 years’ experience with FDA21CFR part 820, ISO13485, ISO14971, and Good Manufacturing Practices (GMP).
• Experience with risk activities using FMECA, including specifically DFMECA and PFMECA and risk management tools.
• Experience in Process Verification & Validation; development and execution of validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Proficiency in test method development and validation (TMV).
• Experience in root cause investigations using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts).
• Proficiency in Six sigma and lean principles.
• Experience with CAPA (corrective and preventive actions) and NCMR (non-conforming material report) investigation and corrective action implementation.
• Proficiency in statistical analysis tools including process capability and measurement system analysis, and tolerance interval analysis with proficiency in Minitab.
• Experience in design and manufacturing documentation to include specifications, procedures, and sampling methods.

Work Location: Irvine, CA. This role requires full-time on-site presence 5 days a week, offering the opportunity to work in a vibrant and innovative environment in the heart of Southern California's technology and manufacturing hub.