Compliance Specialist — Audit Program

Job overview

Compliance Specialist — Audit Program is a hybrid role in Sunnyvale, CA, with three days onsite. Compensation is $37–$38 per hour. The position administers internal and external quality audit processes and supports quality and regulatory compliance programs. The role helps ensure audit findings are addressed effectively and on time by coordinating corrective and preventive actions, monitoring metrics, and working with cross-functional partners. It also supports inspection readiness and continuous improvement of audit and compliance processes.

What you'll do

• Coordinate external audit administration, logistics, and preparation
• monitor audit findings and corrective actions for timely completion
• develop and facilitate audit metrics reporting
• execute governance reviews and provide senior management visibility
• support engineering change orders and QMS projects
• maintain and improve the internal audit module and related training
• monitor policy adherence and coordinate investigations and reports.

What we're looking for

Skills & competencies

compliance specialist

audit program

hybrid

sunnyvale ca

eteam

$37–$38/hr

medical device compliance

internal audits

external audits

corrective actions

iso 13485

21 cfr 820

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree or equivalent experience in engineering, physical or biological science, or another technical field; 2–3 years of medical-device compliance experience; and knowledge of EU MDR, ISO 13485:2016, MDSAP, 21 CFR 820, Health Canada, and other international requirements. Quality Auditor or ISO Lead Auditor certification is desired.

About the employer

eTeam Inc. is hiring for this role. Industry: Offices of All Other Miscellaneous Health Practitioners. Sector: 62.