Quality Engineer II — Design Control & Compliance Leader

Talentify; Covington (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

BD, a global medical technology leader, seeks 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 teams to ensure compliance with quality systems while supporting new product development and process improvements.

You will develop and approve DHFs, CAPAs, validation and risk management documentation, perform audits, and drive corrective actions to sustain quality.

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 Quality representative on cross-functional project teams and apply Design Control principles.
• Provide QA leadership and guidance to project teams and quality organization.
• Develop, review, and approve Quality System documentation (CAPAs, audit reports, quality records).
• Create/approve DHFs and supporting design documentation.
• Develop/approve validation protocols and reports (process, product, stability).
• Create/approve risk management docs (FMEA, FMECA, FTA).
• Investigate nonconformances and lead CAPA activities for improvements.
• Conduct internal and supplier quality audits for regulatory compliance.
• Review and investigate customer complaints for timely resolution.
• Monitor and trend key quality metrics for improvement opportunities.
• Collaborate with manufacturing sites to support quality objectives.

Skills

Quality engineering

Regulatory knowledge

Statistical analysis

Education

Bachelor's of Engineering (BME or EE)

Masters of Engineering

Tools

ASQ Certification

Job description

BD, a global medical technology leader, seeks 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 teams to ensure compliance with quality systems while supporting new product development and process improvements.

You will develop and approve DHFs, CAPAs, validation and risk management documentation, perform audits, and drive corrective actions to sustain quality.