Quality Compliance Audit Manager

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

Position Summary

B. Braun Medical Inc., a leader in infusion therapy and healthcare solutions, is seeking a Quality Compliance Audit Manager to lead and support global quality and regulatory compliance initiatives across our manufacturing and operational sites. In this role, 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). You will serve as a subject matter expert on quality and regulatory requirements while supporting sites during regulatory inspections and certification activities. This position requires strong leadership, project management, and communication skills, along with the ability to influence quality excellence across the organization. This role reports to the Quality organization and may require frequent travel.

In this role, you will have the opportunity to:

• 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.

Essential Requirements

• 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.

Preferred Experience

• Medical device, pharmaceutical, or other highly regulated manufacturing environments.
• Supplier quality management and audit program development.
• Regulatory inspection readiness and response management.
• Experience interpreting and implementing global regulatory requirements.

Salary Range- $122,735 - $153,419/ Annual

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.

To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.