The Quality Engineer is responsible for ensuring the overall quality of the production processes A&M Biomedical provides it’s customers. The QE is tasked with creating documentation, devising quality tests and defining the criteria a test result should meet. The QE reviews drawings, authors MPs/protocols/test reports, and is interacts with customers to gather all necessary requirements for new manufacturing projects. This role involves review of manufacturing processes, inspection and testing methods, tooling and equipment to ensure that our processes and our customer’s products meet established quality standards. The QE conducts NCR and CAPA investigations, vendor qualification and monitoring, and implements quality controls and monitors their effectiveness. The QE works closely with both RA/QA and Operations to ensure our production projects meet or exceed all applicable quality and customer requirements.

• Schedule and lead customer meetings, provide meeting agendas and minutes.
• Create project schedules and keep project on track via milestone and review meetings.
• Draft assembly and inspection procedures for new production projects and revise procedures for existing projects. 
• In cooperation with the Operations Manager, develop and implement methods to inspect, test and evaluate the reliability of manufacturing and production processes. 
• In cooperation with RA/QA representative, determine and incorporate appropriate quality checkpoints/processes in assembly and quality processes.
• Inspect and test materials, equipment, processes, and products to ensure quality specifications are met.
• Review of quality records to ensure compliance with quality standards.
• Ensure processes adhere to company, customer, and industry quality standards.
• Monitor and analyze quality performance using KPIs.
• Ensure that workflows, processes, and products comply with safety regulations.
• Investigate and document quality problems via Nonconformance Reports, CAPAs, and SCARs.
• Prepare reports by collecting, analyzing and summarizing data.
• Oversee and participate in verification and validation activities.
• Identify quality improvement factors and work together with relevant team members to improve processes.
• Write and review production-related items for FMEA/Risk Analysis

Qualifications

• Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
• 4 years' of industry experience
• Strong knowledge of quality tools used in the industry
• Analytical and quantitative approach to problem solving