Remote Quality Compliance Audit Manager

B. Braun; Bethlehem (Northampton County); On-site; USD 123,000 - 153,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. in Bethlehem, PA is seeking a Quality Compliance Audit Manager to lead and support global quality and regulatory compliance initiatives across manufacturing and operations.

You will manage internal and supplier audit programs, drive FDA and ISO compliance, and partner with cross-functional teams to ensure an effective QMS. Frequent travel may be required. The role requires a strong background in quality, regulatory affairs, auditing, and certifications, with leadership and

Qualifications

• Bachelor’s degree in a scientific, engineering, or related discipline; Master’s degree preferred.
• 10+ years of experience in Quality, Regulatory Affairs, Compliance, Auditing, or a related regulated industry.
• Professional auditing or quality certification preferred (ASQ, ISO Lead Auditor, or equivalent).
• Strong knowledge of FDA regulations, ISO 13485, MDSAP, and global quality systems.
• Demonstrated experience leading audits, regulatory inspections, and compliance improvement initiatives.
• Excellent project management, communication, and cross-functional leadership skills.
• Ability to travel frequently to support audits and site compliance activities.

Responsibilities

• Lead internal and supplier audit programs to ensure compliance with FDA, ISO, MDSAP, and other global regulatory requirements.
• Conduct gap assessments of new and revised regulations and drive implementation projects across sites.
• Partner with manufacturing and quality teams to maintain and continuously improve the Quality Management System.
• Support regulatory inspections, third-party audits, and certification activities, including audit preparation and response management.
• Develop and deliver training programs to strengthen compliance knowledge and audit readiness across the organization.
• Monitor quality system certifications and collaborate with notified bodies to maintain compliance status.
• Provide expert guidance on regulatory trends, industry best practices, and quality compliance strategies.
• Travel frequently to support audits and site compliance activities.

Skills

Quality

Regulatory affairs

Auditing

FDA regulations

ISO 13485

MDSAP

Cross-functional leadership

Project management

Communication

Travel readiness

Education

Bachelor’s degree in science/engineering

Master’s degree preferred

Job description

B. Braun Medical Inc. in Bethlehem, PA is seeking a Quality Compliance Audit Manager to lead and support global quality and regulatory compliance initiatives across manufacturing and operations.

You will manage internal and supplier audit programs, drive FDA and ISO compliance, and partner with cross-functional teams to ensure an effective QMS. Frequent travel may be required. The role requires a strong background in quality, regulatory affairs, auditing, and certifications, with leadership and