Job Title: Global Audit Manager
Location: Lakewood, CO (open to relocation)
Schedule: Onsite 9am-5pm 
Salary: $120,000.00 to $150,000.00 + 10% Annual Bonus

Job Description:
We are seeking a highly experienced Global Audit Manager to join our team. The ideal candidate will have at least 7 years of experience in Quality Assurance and/or Regulatory Affairs, with a focus on US FDA Class II or Class III medical devices. The role requires expertise in applying global device laws and regulations, particularly in areas such as adverse event reporting and product recalls. A minimum of 2 years of supervisory experience is required, along with proficiency in FDA Quality System Regulations and ISO 13485.

Key Responsibilities:

Audit Management (Internal, External, Supplier): Lead and manage the Audit function, including internal, external, and supplier audits. This will involve creating annual audit schedules, executing plans, and ensuring audits are conducted according to schedule. Audit Expertise & Regulatory Compliance: Serve as the primary point of contact for regulatory and compliance issues. Provide expertise in audits and inspections, particularly for regulatory bodies such as FDA and Notified Bodies. Ensure that policies and procedures are compliant and effective. QMS Leadership & Improvement: Own, manage, and execute the Quality Management System (QMS) audit processes. This includes remediation of internal audits, supporting regulatory audits, and identifying continuous improvement opportunities. Monitor and report on the health of the QMS area, providing metrics and reporting to senior management and oversight boards. Subject Matter Expert: Act as a Subject Matter Expert and Process Owner for the QMS areas of responsibility during audits and inspections. Host or lead the audit process as required, and ensure that all stakeholders are aligned and compliant.

Qualifications:

Minimum 7 years of experience in Quality Assurance and/or Regulatory Affairs, with a focus on medical device regulations (US FDA Class II or III). Minimum 2 years of supervisory or managerial experience. Experience leading or hosting regulatory audits (e.g., MDSAP, FDA, Notified Body). Preferred training in FDA Quality System Regulations and ISO 13485. Bachelor’s degree in a science related field.  This position provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.

There is an expansive list of benefits offerings including multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.

To help you save for retirement, there is a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.

#M3


Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.