MedTech Design Quality Leader — Senior Engineer

RXinsider LTD.; Covington (GA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

On-site work requirement

Collaboration across sites

Job summary

BD is seeking a Senior Design Quality Engineer to act as the guardian of quality for our medical device products, ensuring design controls, risk management, and documentation meet regulatory expectations and patient safety standards.

You will lead QA initiatives across the product lifecycle, mentor engineers, collaborate with contract manufacturers, and drive continuous improvement through robust validation, audits, and CAPA processes within a fast-paced, compliance-driven environment.

Qualifications

• Bachelor's Degree in Engineering and 4 Quality Engineering experience in a regulated environment OR Master's Degree and 2 years of Quality Engineering experience in a regulated environment.
• Regulatory knowledge and experience including FDA, MDSAP, PMDA, CFDA and supplier quality.
• Experience interpreting regulations, conducting risk assessments, and leading QA initiatives.

Responsibilities

• Quality Leadership Across the Product Lifecycle: own Design Control, Document Control, and QA processes from concept to commercialization.
• Strategic Partnership: collaborate with contract manufacturers and internal plants to implement changes while upholding high quality standards.
• Proactive Risk Management: monitor complaint trends and drive corrective actions.
• Subject Matter Authority: be the go-to resource for cross-functional teams in Engineering and Operations.
• Lead Quality Initiatives: provide QA leadership for project teams and the QA department.
• Master Documentation: build, review, and approve QA documents including CAPAs and audit reports.
• Audit with Authority: conduct internal and supplier audits to ensure compliance across the supply chain.

Skills

Quality Engineering

Regulatory knowledge

Leadership

Problem solving

Education

Bachelor's Degree in Engineering

Master's Degree (Engineering)

Tools

ASQ Certification

FDA/MDSAP/PMDA/CFDA familiarity

Job description

BD is seeking a Senior Design Quality Engineer to act as the guardian of quality for our medical device products, ensuring design controls, risk management, and documentation meet regulatory expectations and patient safety standards.

You will lead QA initiatives across the product lifecycle, mentor engineers, collaborate with contract manufacturers, and drive continuous improvement through robust validation, audits, and CAPA processes within a fast-paced, compliance-driven environment.