Senior Design Quality Engineer | Lead Product Quality & Risk

BD; Covington (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

BD is seeking a Senior Design Quality Engineer to guard quality for a critical product family, ensuring robust design controls and compliance across the lifecycle. You will lead QA processes, partner with contract manufacturers, monitor risk, and drive CAPA actions to protect patient safety.

You will mentor staff, develop design history files, and contribute to advanced validation and testing programs in a fast-paced medical device environment.

Qualifications

• Bachelor's Degree in Engineering with 4 Quality Engineering experience in a regulated environment OR
• Master's Degree with 2 years of Quality Engineering experience in a regulated environment

Responsibilities

• Quality leadership across the product lifecycle, owning Design Control and QA processes
• Collaborate with contract manufacturers and internal plants to implement changes with quality
• Monitor complaint trends and execute swift corrective actions
• Serve as the go-to SME for cross-functional teams in Engineering, Operations, and supplier management
• Lead Design Control excellence on projects and product development initiatives
• Build, review, and approve critical Quality System Documents including CAPAs and audit reports
• Create and approve Design History Files and Validation documents
• Develop risk assessments using FMEA, FMECA, and FTA
• Mentor staff and supervise technicians and engineers
• Drive corrective and preventive actions and monitor quality metrics
• Conduct internal and supplier quality system audits
• Engage with trade bodies to bring industry standards to the team
• Perform complaint reviews and root-cause investigations
• Track quality indicators to demonstrate continuous improvement
• Coordinate with sites for quality consistency
• Chair design reviews as Independent QA Reviewer

Skills

Design Controls

QA Leadership

Regulatory Knowledge

Risk Management

Statistical Analysis

IEC 60601 Knowledge

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Tools

CAPA Software

Document Management System

Job description

BD is seeking a Senior Design Quality Engineer to guard quality for a critical product family, ensuring robust design controls and compliance across the lifecycle. You will lead QA processes, partner with contract manufacturers, monitor risk, and drive CAPA actions to protect patient safety.

You will mentor staff, develop design history files, and contribute to advanced validation and testing programs in a fast-paced medical device environment.