Quality Engineer II - Design Control & QA Leadership

Regulatory Jobs; Covington (GA); On-site; USD 80,000 - 110,000; Full time

Job summary

BD is seeking a Quality Engineer to own QA, document control and design control within their product line. You will partner with Manufacturing, R&D, Product Development, and Quality to ensure compliance and drive product improvements.

Responsibilities include leading CAPAs, auditing, DHF/document development, and risk management while supporting new product development and process changes. Travel up to 15% may be required.

Qualifications

• Bachelor's degree in Engineering (BME or EE) required.
• 2 years of Quality Engineering experience in a regulated environment.
• Willingness to travel internationally up to 15%.

Responsibilities

• Lead Quality Assurance and Design Control activities for assigned product lines.
• Develop, review, and approve quality system documentation (CAPAs, audits).
• Create and approve DHFs and design documentation; validate protocols and reports.
• Investigate nonconformances; drive corrective and preventive actions.
• Perform and participate in internal and supplier quality audits.
• Monitor and trend quality metrics; partner with sites for continuous improvement.
• Chair Design Review activities and act as independent QA reviewer.

Skills

Quality Engineering

Design Control

Documentation Control

CAPA management

Risk management

FMEA / FMECA / FTA

FDA/regulatory knowledge

Statistical analysis

Travel up to 15%

Education

Bachelor's of Engineering (BME or EE)

Masters of Engineering

ASQ Certification

Tools

DHFs

Job description

BD is seeking a Quality Engineer to own QA, document control and design control within their product line. You will partner with Manufacturing, R&D, Product Development, and Quality to ensure compliance and drive product improvements.

Responsibilities include leading CAPAs, auditing, DHF/document development, and risk management while supporting new product development and process changes. Travel up to 15% may be required.