Senior Design Quality Engineer - Innovation & Compliance

BD Mexico; Covington (GA); On-site; USD 120,000 - 160,000; Full time

Job summary

BD is a global medical technology leader seeking a Quality Engineering leader to guide Quality Engineers, Technicians, and Inspectors. You will drive quality systems, validation, and compliance programs across FDA-regulated activities in a fast-paced environment.

You will develop risk assessments, lead design controls, coordinate design verification/validation, and support regulatory submissions while mentoring junior staff and collaborating with cross-functional teams.

Qualifications

• B.S. and 8 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving OR
• M.S. and 6 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving.
• Ability to Travel

Responsibilities

• Provide technical leadership and guidance to Quality Engineers, Quality Technicians, and Inspectors.
• Lead and support quality engineering projects that enhance quality systems, procedures, and compliance processes.
• Develop test protocols and final reports to support regulatory submissions, including FDA 510(k), PMA, CE Mark, and international product registrations.
• Support early-stage product innovation activities by contributing quality expertise during pre-concept and front-end development of new technologies.
• Develop and maintain Risk Management Files, coordinating input across cross-functional design teams.
• Participate in the creation and execution of Design Verification and Design Validation protocols, analyze results, and determine overall design acceptability.
• Contribute to project Trace Matrices, Product Performance Specifications, Product Development Plans, and other design control documentation in accordance with the BD UCC product development process.

Skills

Quality engineering leadership

FDA QSR compliance

Risk management

DFMEA PFMEA

Design controls

DOE analysis

Statistical methods

Vendor qualification

Regulatory submissions

Education

Bachelor's in Engineering

Master's in Engineering

Job description

BD is a global medical technology leader seeking a Quality Engineering leader to guide Quality Engineers, Technicians, and Inspectors. You will drive quality systems, validation, and compliance programs across FDA-regulated activities in a fast-paced environment.

You will develop risk assessments, lead design controls, coordinate design verification/validation, and support regulatory submissions while mentoring junior staff and collaborating with cross-functional teams.