Senior Quality Assurance Engineer

Position Summary

Our client, a leading medical device company, is seeking a Quality Engineer to support manufacturing and product quality initiatives. This individual contributor role is responsible for developing, implementing, and improving quality processes to ensure products meet design specifications, regulatory requirements, and customer expectations. The ideal candidate will work independently, apply sound engineering judgment, and collaborate cross-functionally to drive continuous improvement and defect reduction.

Key Responsibilities

• Develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products are free of defects and perform as intended.
• Design, install, and utilize testing equipment to support product testing, validation, and failure analysis.
• Perform detailed product testing and data analysis to maintain quality levels and minimize defects and failure rates.
• Analyze quality data, inspection results, and nonconforming material to identify trends and recommend corrective and preventive actions (CAPA).
• Lead or support investigations related to product defects, process deviations, and quality events.
• Collaborate with suppliers and supplier quality representatives to resolve quality issues and ensure effective corrective actions are implemented.
• Contribute to and support supplier quality improvement initiatives.
• Create and maintain quality documentation in accordance with internal procedures and regulatory requirements.
• Participate in continuous improvement efforts to enhance manufacturing and quality system effectiveness.
• Support audits, inspections, and other quality-related activities as needed.
  
  

Qualifications

• Bachelor’s degree in Engineering or a related technical discipline (or equivalent experience).
• Minimum of 4 years of relevant quality engineering experience, preferably within a regulated manufacturing or medical device environment.
• Strong understanding of process control, inspection techniques, root cause analysis, and corrective actions.
• Demonstrated ability to analyze data, identify trends, and make sound, detail-oriented evaluative judgments.
• Experience working independently with minimal supervision while managing multiple priorities.
• Strong written and verbal communication skills with the ability to collaborate cross-functionally.
• Familiarity with quality systems, manufacturing processes, and supplier quality management.