Senior Design Quality Engineer & Technical Lead

Regulatory Jobs; Covington (GA); On-site; USD 110,000 - 150,000; Full time

Job summary

BD in Covington, GA is seeking an experienced Quality Engineer to provide leadership across quality, design controls, and regulatory submissions. You will guide cross-functional teams to ensure compliance and drive robust risk management programs.

You will develop and execute test protocols, support FDA and international registrations, and continuously improve product development processes while maintaining cGMP, ISO13485, and ISO9001 standards.

Qualifications

• BS or MS with 6–8 years in quality engineering including design controls and risk management.
• Experience with FDA QSR and ISO13485/ISO9001 compliance.

Responsibilities

• Provide technical leadership to Quality Engineers and Inspectors.
• Develop test protocols and final reports for regulatory submissions (FDA 510(k), PMA, CE Mark).
• Lead or support risk management activities including AFMEA, DFMEA, PFMEA.
• Coordinate and document design verification and validation activities.

Skills

Quality engineering

Statistical methods

Six Sigma

Design controls

Risk management

FDA QSR knowledge

Education

BS in Quality Engineering

MS in Quality Engineering

Tools

Gage R&R

DOE

Process capability

Job description

BD in Covington, GA is seeking an experienced Quality Engineer to provide leadership across quality, design controls, and regulatory submissions. You will guide cross-functional teams to ensure compliance and drive robust risk management programs.

You will develop and execute test protocols, support FDA and international registrations, and continuously improve product development processes while maintaining cGMP, ISO13485, and ISO9001 standards.