Global Quality Audit & Compliance Lead

RXinsider LTD.; Bethlehem, Northern (Northampton County, KY); Hybrid; USD 123,000 - 153,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking a Quality Compliance Audit Manager to lead global quality and regulatory initiatives across manufacturing and operations.

You will manage audit programs, drive FDA and ISO compliance, and partner with cross-functional teams to strengthen the Quality Management System. Travel to sites will be frequent. Essential requirements include a science/engineering degree and 10+ years in quality or regulatory roles, with auditing certification preferred.

Qualifications

• Bachelor's degree in scientific/engineering field; Master's degree preferred.
• 10+ years in Quality, Regulatory, Compliance, Auditing, or related regulated industry.
• Auditing certification desirable (ASQ, ISO Lead Auditor).
• Strong knowledge of FDA regulations, ISO 13485, MDSAP, and global QMS.
• Experience leading audits and regulatory inspections.

Responsibilities

• Lead internal and supplier audit programs for FDA/ISO/MDSAP compliance.
• Conduct gap assessments and drive cross-site implementation projects.
• Support regulatory inspections, third-party audits, and certification activities.
• Develop training to improve audit readiness and compliance knowledge.

Skills

Quality management

Regulatory affairs

Auditing

Project management

Cross-functional leadership

Education

Bachelor's degree in science/engineering

Master's degree preferred

Job description

B. Braun Medical Inc. is seeking a Quality Compliance Audit Manager to lead global quality and regulatory initiatives across manufacturing and operations.

You will manage audit programs, drive FDA and ISO compliance, and partner with cross-functional teams to strengthen the Quality Management System. Travel to sites will be frequent. Essential requirements include a science/engineering degree and 10+ years in quality or regulatory roles, with auditing certification preferred.