Senior Audit & Compliance Specialist

eTeam; Sunnyvale (CA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

eTeam seeks a Compliance Specialist 3 in Sunnyvale, CA. Hybrid role with 3 days onsite, 12-month duration. You will manage external audits, monitor findings, and report compliance metrics while supporting quality and regulatory programs across cross-functional teams.

The ideal candidate has a Bachelor's degree or equivalent in a technical field, 2–3 years in medical device compliance, and knowledge of EU-MDR, ISO 13485, MDSAP, and 21 CFR 820. Certification as a QA Auditor is a plus.

Qualifications

• Bachelor's Degree or equivalent in Engineering, physical or biological science or other technical field.
• 2-3 years of experience in compliance role in the medical device industry.
• Working knowledge of project management tools and techniques.
• Knowledge of EU-MDR, ISO 13485:2016; MDSAP, and 21 CFR 820 requirements, Health Canada, and other international regulatory requirements.
• Certified Quality Auditor/ISO Lead Auditor certification desired.
• Demonstrated ability to work with cross-functional/cross-plant project teams.
• Experience interpreting and guiding domestic and international regulations as applicable to the QMS.
• Strong organizational, written and verbal communication skills, ability to prioritize tasks in deadline-driven environment.
• Strong interpersonal skills and ability to work with people at all levels.

Responsibilities

• Manage external audit administration activities, including coordination, logistics and preparation for external audits
• Monitor audit finding related activities to ensure timely completion
• Develop and facilitate reporting of audit-related metrics to ensure compliance
• Execute governance process for timely review of audit findings and reporting to Senior Management
• Promote a culture of compliance to regulations, standards, and procedures and risk management
• Serve as liaison for engineering change orders/QMS project support
• Lead and refine internal audit module, troubleshoot issues, and provide training
• Monitor adherence to corporate policies and coordinate investigations and reporting

Skills

Project management tools

Regulatory knowledge

Cross-functional collaboration

Auditing

Communication skills

Interpersonal skills

Education

Bachelor's degree or equivalent

Job description

eTeam seeks a Compliance Specialist 3 in Sunnyvale, CA. Hybrid role with 3 days onsite, 12-month duration. You will manage external audits, monitor findings, and report compliance metrics while supporting quality and regulatory programs across cross-functional teams.

The ideal candidate has a Bachelor's degree or equivalent in a technical field, 2–3 years in medical device compliance, and knowledge of EU-MDR, ISO 13485, MDSAP, and 21 CFR 820. Certification as a QA Auditor is a plus.