Job Details

 Pay 55-70/h depending on exerience

Your 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 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.

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