Lead Design Quality Engineer

Regulatory Jobs; Covington (GA); On-site; USD 110,000 - 160,000; Full time

Job summary

BD in Covington, GA is seeking a senior Quality Engineer to provide technical leadership to Quality Engineers, Technicians and Inspectors, supporting regulatory submissions and compliance.

You will develop test protocols, manage risk files, perform design verification/validation, lead DFMEA/PFMEA, and ensure 21 CFR 820 and ISO 13485 adherence across internal and outsourced manufacturing.

Qualifications

• B.S. with 8+ years in quality engineering; design controls, validation and risk management.
• M.S. with 6+ years in quality engineering; design controls, validation and problem solving.

Responsibilities

• Provide technical leadership to Quality Engineers, Technicians and Inspectors.
• Lead quality engineering projects improving quality systems and compliance.
• Develop test protocols and final reports for regulatory submissions (FDA 510(k), PMA, CE).
• Support pre-concept and front-end development with quality expertise.
• Maintain Risk Management Files and coordinate cross-functional input.
• Lead Design Verification/Validation protocols and assess design acceptability.

Skills

Quality leadership

Design controls

Statistical methods

Six Sigma tools

Risk management

FDA QSR

ISO 13485

ISO 9001

CAPA

Mentoring

Education

Bachelor's degree in a related field

Master's degree

Tools

Gage R&R

Design of Experiments (DOE)

Job description

BD in Covington, GA is seeking a senior Quality Engineer to provide technical leadership to Quality Engineers, Technicians and Inspectors, supporting regulatory submissions and compliance.

You will develop test protocols, manage risk files, perform design verification/validation, lead DFMEA/PFMEA, and ensure 21 CFR 820 and ISO 13485 adherence across internal and outsourced manufacturing.