Senior Design Quality Engineer – Shape Safer Medical Devices

RXinsider LTD.; Covington (GA); On-site; USD 100,000 - 150,000; Full time

Job summary

BD seeks a Senior Design Quality Engineer to safeguard patient safety by owning Design Control and QA processes across the product lifecycle. You will partner with manufacturing and engineering teams, lead risk assessments, validate documentation, and drive continuous improvement in a fast-paced regulated environment.

The role emphasizes on-site collaboration, strong regulatory knowledge, and the ability to influence cross-functional teams.

Qualifications

• Bachelor's Degree in Engineering and 4 Quality Engineering experience in a regulated environment.
• Master's Degree and 2 years of Quality Engineering experience in a regulated environment.
• Knowledge of FDA, MDSAP, PMDA, CFDA regulatory frameworks.
• Experience with Design Control, CAPAs, and risk management methodologies.

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 maintaining quality standards.
• Proactive Risk Management: Monitor complaint trends and execute corrective actions.
• Subject Matter Authority: Be the go-to resource for cross-functional teams in Engineering, Operations, and supplier management.
• Champion Design Control Excellence: Ensure design control principles are woven into Product and Process Changes and New Product Development.
• Lead Quality Initiatives: Provide QA leadership for Project Teams and the Quality Department.
• Master Documentation: Build, review, and approve critical Quality System Documents including CAPAs and audit reports.
• Craft Compliance Artifacts: Create and approve Design History Files and DFMEA, DMRs, and validation documents.

Skills

Problem solving

Detail oriented

Regulatory knowledge

Statistical analysis

IEC 60601 knowledge

Supplier quality experience

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Job description

BD seeks a Senior Design Quality Engineer to safeguard patient safety by owning Design Control and QA processes across the product lifecycle. You will partner with manufacturing and engineering teams, lead risk assessments, validate documentation, and drive continuous improvement in a fast-paced regulated environment.

The role emphasizes on-site collaboration, strong regulatory knowledge, and the ability to influence cross-functional teams.