Quality Assurance Engineer

The Quality department is responsible for maintaining the integrity of Guidant's Quality Management System (QMS) for Measurement Solutions, Americas to the ISO 9001 and any other required regulatory standards. The department champions quality and provides leadership with the aim of gaining continuous commitment from employees while assuring compliance to our clients, regulatory and statutory requirements, and promoting client success.

Responsibilities

• Serves as primary vendor contact for Quality related issues.
• Ensures Suppliers maintain consistent product quality through management of inspection plans, periodic FAIs and Audits, coordination of vendor corrective actions as required.
• Ensures product quality within the shop environment by identifying sources of non-conformance or waste and providing solutions (immediate and long-term) for both production and aftermarket shop activities.
• Performs Root Cause Analysis as needed, identifies opportunities for improvement, analyzes and reduces disruptions to product execution, and implements solutions or drives preventive actions.
• Authorize to Ship evaluations of vendor shipments as needed.
• Lead MRB and Receiving Inspection areas by establishing daily work priorities, coordinating vendor returns, reviewing MRB QN submissions.
• Maintain monthly performance metrics (MRB Inventory, Scrap, QN performance).
• Support Buyers, Product Quality Engineer and Document Coordinator on FAI requirements and outgoing FAI Reviews as needed.
• Care for Quality and Engineering teams to maintain appropriate receiving inspection levels.
• Maintain Supplier Quality Score Cards and report on supplier performance as needed.

Qualifications

• BS Degree in Materials, Industrial, Mechanical or Engineering Technology.
• 5 or more years’ experience in Quality role.
• Proficient PC skills including Microsoft Office and statistical analysis packages; use of CAD and analysis software appropriate to the engineering specialty.
• Able to productively work with others, on a team, and often influence others who are not direct reports.
• Strong statistical skills.
• Able to establish deadlines and manage multiple tasks and priorities.
• Strong accuracy and attention to detail.
• Effective written and verbal communication skills in English.
• Able to receive constructive feedback and coaching and respond appropriately.
• Able to identify compliance and technical risk and assist in developing appropriate mitigation strategies.

Preferred

• ASQ Certification in Quality Engineering Root Cause and Corrective Action and FMEA experience.
• Knowledge of inspection tools, measurement, and calibration system techniques.
• Knowledge of ISO 9001 (International Standard Organization).
• Knowledge of castings, welding/ fabrication, precision machining, electronic and mechanical assembly processes.
• Power BI experience.
• Interest in AI tool learning.