Remote Quality Compliance Audit Leader

B. BRAUN MEDICAL (US) INC; Bethlehem (Northampton County); Remote; 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 and support global quality and regulatory compliance initiatives across manufacturing and operational sites.

You will manage internal and supplier audit programs, drive compliance with FDA and international regulations, and partner with cross-functional teams to ensure the effectiveness of the Quality Management System (QMS). This role requires strong leadership, project management, and communication skills, with travel

Qualifications

• Bachelor’s degree in science/engineering; Master’s preferred.
• 10+ years in Quality, Regulatory Affairs, or Auditing.
• Strong knowledge of FDA, ISO 13485, MDSAP.
• Experience leading audits and regulatory inspections.

Responsibilities

• Lead internal and supplier audits across sites.
• Ensure compliance with FDA, ISO, MDSAP and other regulations.
• Partner with manufacturing and quality teams to improve QMS.
• Support regulatory inspections and certification activities.
• Develop and deliver training on compliance and audits.
• Monitor quality system certifications with notified bodies.
• Provide guidance on regulatory trends and best practices.

Skills

Quality

Regulatory

Auditing

Leadership

Project management

Education

Bachelor’s degree

Master’s degree preferred

Job description

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

You will manage internal and supplier audit programs, drive compliance with FDA and international regulations, and partner with cross-functional teams to ensure the effectiveness of the Quality Management System (QMS). This role requires strong leadership, project management, and communication skills, with travel