Senior Design Quality Engineer - Lead in MedTech Quality

Becton, Dickinson and Company; Covington (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

Becton, Dickinson and Company in Covington, GA is seeking a Senior Quality Engineer to own QA/Document Control/Design Control within a medical device product line. You will lead cross-functional teams, drive design control adherence, and champion CAPA and risk management processes.

The role collaborates with Engineering, Operations, and suppliers to ensure regulatory compliance and product quality, with opportunities to mentor team members and influence quality systems across BD.

Qualifications

• BS or MS in Engineering (BME/EE/ME).
• 5 years in FDA-regulated environment.
• 3 years of product design experience.
• 2 years of Quality Engineering in a regulated setting.
• Knowledge of Design Controls, CAPA, risk assessment, and statistics.

Responsibilities

• Serve as Quality representative on cross-functional project teams applying Design Control principles to product and process changes and new product development activities.
• Provide Quality Assurance leadership and guidance to project teams and within the Quality organization.
• Author, review, and approve Quality System documentation, including CAPAs, audit reports, and related quality records.
• Develop, review, and approve product quality documentation, including Design History Files (DHFs) and other design control deliverables.
• Create, review, and approve validation protocols and reports for products, processes, software, and stability studies.
• Lead and support risk management activities, including the development and review of FMEA, FMECA, FTA, and other risk assessment documentation.
• Analyze product and process nonconformances, determine root causes, and drive robust corrective and preventive action (CAPA) plans.
• Perform internal and supplier quality system audits to ensure compliance with regulatory and quality standards.
• Review and investigate product complaints, supporting timely resolution and continuous improvement efforts.
• Monitor, track, and trend key quality metrics and indicators to identify risks and improvement opportunities.
• Partner closely with manufacturing sites and other division facilities to ensure consistent quality practices and compliance across operations.
• Serve as an independent Quality Assurance reviewer and chair Design Reviews to ensure objective evaluation of product development activities.
• Mentor and develop quality professionals, technicians, and engineers through coaching, knowledge sharing, and technical guidance.
• Provide oversight and supervision for technicians and engineers, supporting performance, development, and project execution.
• Maintain awareness of evolving industry trends, regulations, and best practices through participation in professional organizations and industry forums, and communicate relevant insights to the business.

Skills

Detail oriented

Regulatory knowledge

Statistical analysis

Education

BS/MS Engineering (BME/EE/ME)

ASQ Certification

Job description

Becton, Dickinson and Company in Covington, GA is seeking a Senior Quality Engineer to own QA/Document Control/Design Control within a medical device product line. You will lead cross-functional teams, drive design control adherence, and champion CAPA and risk management processes.

The role collaborates with Engineering, Operations, and suppliers to ensure regulatory compliance and product quality, with opportunities to mentor team members and influence quality systems across BD.