Senior QMS Internal Auditor – Medical Device ISO 13485

BiVACOR Inc; Huntington Beach (CA); On-site; USD 126,000 - 138,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, dental, and vision insurance

Life insurance & Employee Assistance Program

Generous paid time off

Job summary

BiVACOR Inc in Huntington Beach, California is looking for an experienced QMS Internal Auditor who will play a crucial role in ensuring quality standards and regulatory compliance for our life-saving artificial heart technology. This position requires strong expertise in ISO 13485 and direct internal auditing experience. The expected salary range is $126,000 to $138,000, along with comprehensive benefits including 401(k) matching, medical, dental, and vision insurance.

Qualifications

• 10+ years of experience in Quality Assurance within the medical device industry.
• 5+ years of internal auditing experience against ISO 13485 and/or 21 CFR Part 820.
• Experience with Class III medical device development preferred.

Responsibilities

• Develop annual internal audit schedule based on risk and regulatory requirements.
• Conduct audits of QMS processes including design controls and supplier quality.
• Document nonconformities and assign audit findings through closure.

Skills

Quality Assurance

Internal Auditing

ISO 13485 Knowledge

FDA Regulations Familiarity

Risk Management

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Electronic QMS platforms

Job description

BiVACOR Inc in Huntington Beach, California is looking for an experienced QMS Internal Auditor who will play a crucial role in ensuring quality standards and regulatory compliance for our life-saving artificial heart technology. This position requires strong expertise in ISO 13485 and direct internal auditing experience. The expected salary range is $126,000 to $138,000, along with comprehensive benefits including 401(k) matching, medical, dental, and vision insurance.