Contract Audit Program Manager - Medical Devices (Hybrid)

BBG Ventures, LLC; Sunnyvale (CA); Hybrid; USD 90,000 - 120,000; Part time

Benefits offered by this job

Medical

Dental

Vision

401k

Job summary

Our Customer in Sunnyvale, CA is seeking an Audit Program Manager on a contract basis to administer internal and external audit processes and ensure compliance with procedures. The role requires experience in medical device regulatory standards and cross-functional collaboration.

The position is hybrid in Sunnyvale, CA, overseeing audit findings, corrective actions, and governance reporting to senior management.

Qualifications

• Bachelor's degree or equivalent in engineering or life sciences.
• 2–3 years of compliance experience in the medical device industry.
• Knowledge of project management tools.
• Familiar with EU-MDR, ISO 13485:2016, MDSAP, and 21 CFR 820.
• Certified Quality Auditor desirable.
• Strong cross-functional collaboration and communication.
• Experience interpreting domestic and international regulations.

Responsibilities

• Manage external audit administration and logistics.
• Monitor audit findings and ensure timely closure.
• Create reporting of audit metrics for compliance.
• Governance process for reviews and visibility to Senior Management.
• Promote culture of regulatory compliance and risk management.
• Liaise for engineering change orders and QMS projects.
• Lead and refine the internal audit module training.
• Investigate violations and coordinate investigations.
• Lead other audit-management related projects.

Skills

Audit management

Regulatory compliance

Cross-functional

Regulatory standards

Project management

Education

Bachelor's degree

Tools

Regulatory databases

Quality systems

Job description

Our Customer in Sunnyvale, CA is seeking an Audit Program Manager on a contract basis to administer internal and external audit processes and ensure compliance with procedures. The role requires experience in medical device regulatory standards and cross-functional collaboration.

The position is hybrid in Sunnyvale, CA, overseeing audit findings, corrective actions, and governance reporting to senior management.