Quality Engineer II: Design Controls & QA Leadership

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

Job summary

BD is seeking a Quality Engineer to own Quality Assurance, Document Control, and Design Control within the product line. You will partner with Manufacturing, R&D, Product Development, and Quality teams to ensure compliance while supporting new product development, changes, and process improvements.

The role requires 2 years in a regulated quality environment, strong knowledge of FDA/regulatory frameworks, and occasional international travel up to 15%.

Qualifications

• Bachelor's degree in Engineering (BME or EE) from an accredited program.
• 2 years of quality engineering experience in a regulated environment.
• Ability to travel internationally up to 15%.

Responsibilities

• Serve as the Quality representative on cross-functional project teams, ensuring Design Control principles are applied throughout product and process changes as well as new product development activities.
• Provide Quality Assurance leadership and guidance to project teams and the broader Quality organization.
• Develop, review, and approve Quality System documentation, including CAPAs, audit reports, and related quality records.
• Create, review, and approve product documentation, including Design History Files (DHFs) and supporting design documentation.
• Develop, review, and approve validation protocols and reports, including process, product, and stability validations.
• Create, review, and approve risk management documentation, including FMEA, FMECA, and Fault Tree Analysis (FTA).
• Investigate product and process nonconformances and lead corrective and preventive action activities to drive sustainable improvements.
• Conduct internal quality system audits and supplier quality audits to ensure compliance with regulatory and company requirements.
• Review and investigate customer complaints as needed, ensuring timely and effective resolution.
• Monitor, analyze, and trend key quality metrics and performance indicators to identify opportunities for improvement.
• Partner with manufacturing sites and other division facilities to support quality objectives and continuous improvement efforts.
• Serve as the independent Quality Assurance reviewer and Chairperson for Design Review activities.

Skills

Quality engineering

Regulatory compliance

Education

Bachelor's in Engineering (BME or EE)

Master of Engineering

Tools

Minitab

CAPA systems

Job description

BD is seeking a Quality Engineer to own Quality Assurance, Document Control, and Design Control within the product line. You will partner with Manufacturing, R&D, Product Development, and Quality teams to ensure compliance while supporting new product development, changes, and process improvements.

The role requires 2 years in a regulated quality environment, strong knowledge of FDA/regulatory frameworks, and occasional international travel up to 15%.