Quality Engineering Senior

Reference: 630073Posted: 2026-08-12Location: Irvine, CACompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io Pay 55-70/h depending on exerienceYour role as a Quality Engineer in the manufacturing sector of Neurovascular products 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. Here’s an overview tailored to emphasize manufacturing aspects:Responsibilities may include the following and other duties may be assigned.Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.Collaborates with engineering and manufacturing functions to ensure quality standards are in place.Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.May specialize in the areas of 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.Disposition of non-conforming material requiring advanced process/technical knowledge.Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventativeactions.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.Must possess at least 2 years’ experience with each of the following:* FDA21CFR part 820, ISO13485, ISO14971, and Good Manufacturing Practices (GMP)* Risk activities using FMECA, including specifically DFMECA and PFMECA and risk management tools* Process Verification & Validation; development and execution of validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)* Test method development and validation (TMV)* Root cause investigations using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts)* Six sigma and lean principles* CAPA (corrective and preventive actions) and NCMR (non-conforming material report) investigation and corrective action implementation* Statistical analysis tools including process capability and measurement system analysis, and tolerance interval analysis with proficiency in Minitab* Design and manufacturing documentation to include specifications, procedures and sampling methods