Quality Assurance Engineer: Design & Compliance

Becton Dickinson NA; Covington (GA); On-site; USD 85,000 - 120,000; Full time

Job summary

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

This role requires a Bachelor’s in Engineering and 2 years of experience in a regulated environment, with up to 15% travel. On-site position located in Covington, GA.

Qualifications

• Bachelor's degree in Engineering (BME or EE) required.
• 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 knowledge

Statistical analysis

Cross-functional teamwork

Education

Bachelor's of Engineering (BME/EE)

Job description

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

This role requires a Bachelor’s in Engineering and 2 years of experience in a regulated environment, with up to 15% travel. On-site position located in Covington, GA.