Senior Quality Auditor

About Syn Cardia Systems, LLC

Syn Cardia Systems, LLC is a wholly owned subsidiary of Picard Medical, Inc. (NYSE: PMI), a publicly traded company as of August 29, 2025. Syn Cardia is a global innovator in total artificial heart technology and develops, manufactures, and commercializes the Syn Cardia Total Artificial Heart (STAH), the only commercially available total artificial heart approved by both the U.S. Food and Drug Administration (FDA) and Health Canada.

We are looking for a meticulous, audit‑driven Senior Quality Auditor to join our Quality team. In this role, you will plan, execute, and continuously improve Syn Cardia's internal and supplier audit programs to ensure full compliance with ISO 13485:2016, 21 CFR Part 820, and MDSAP requirements. You will serve as a key resource for external audit readiness, CAPA oversight, and quality system improvement — while helping build a culture of quality throughout the organization.

If you are passionate about regulatory rigor and making a difference in life‑saving medical device technology, we would love to hear from you.

Internal Audit Program

• Plan, schedule, and conduct internal audits of the Quality Management System (QMS) in accordance with ISO 13485:2016, 21 CFR Part 820, and MDSAP audit model requirements.
• Evaluate procedures, records, and processes to assess compliance and identify systemic risks or areas for improvement.
• Ensure audit documentation is clear, complete, and properly filed, including audit reports, checklists, and objective evidence.

Supplier Quality Audits

• Plan, conduct, and document supplier quality audits in alignment with approved supplier audit schedules.
• Evaluate supplier compliance with applicable regulatory requirements, quality agreements, and Syn Cardia specifications.
• Collaborate with Purchasing and Quality teams to ensure timely resolution of supplier nonconformances and CAPA follow‑ups.

Audit Program Improvement

• Contribute to the continuous improvement of the internal and supplier audit programs through trend analysis, risk‑based planning, and auditor calibration.
• Monitor effectiveness of corrective actions taken in response to audit findings.

Regulatory and Certification Audit Support

• Support preparations for external audits (e.g., MDSAP, FDA, Notified Body) by ensuring internal readiness and follow‑through on internal audit outcomes.
• Serve as an audit escort or scribe during external inspections, as assigned.

CAPA and Quality Records

• Review CAPA records and quality events for completeness and regulatory alignment.
• Verify effectiveness of corrective and preventive actions stemming from audit findings.
• Initiate action to prevent the occurrence of nonconformities relating to product, process, and the Quality System.
• Identify and record potential problems related to the product, process, and Quality System.
• Recommend or provide solutions through designated channels.
• Record and report all instances of supplier or internal audit findings and customer feedback impacting product quality.

Training and Mentorship

• Train internal staff on audit procedures and QMS requirements.
• Mentor junior auditors and provide feedback to improve audit skills and consistency.

Continuous Improvement and Quality Culture

• Drive quality culture by promoting proactive identification and resolution of quality issues.
• Participate in quality system projects and initiatives as assigned.

What We Are Looking For

• Strong auditing and investigative skills with ability to assess risk and identify root causes.
• Excellent verbal and written communication skills.
• Strong organizational skills and high attention to detail.
• Ability to manage multiple audits simultaneously in a fast‑paced environment.
• Proficient in interpreting and applying medical device regulations.
• Independent, self‑motivated, and collaborative in approach.
• Diplomatic and professional in navigating cross‑functional relationships.

• Bachelor's degree in life sciences, engineering, or a related field required.
• Minimum of 5 years of experience in quality systems, including at least 3 years in auditing.
• Experience auditing to ISO 13485, 21 CFR 820, and MDSAP requirements.
• ISO 13485:2016 Lead Auditor Certified or equivalent certification required.
• Experience auditing Class III implantable device manufacturers and suppliers strongly preferred.

• Office‑based workstation
• Frequently required to sit, walk, use hands, and talk or hear
• May occasionally be exposed to cleanroom environments, mechanical parts, or production areas requiring protective clothing
• May involve travel to domestic and international supplier sites
• Must be able to lift and carry audit materials and equipment up to 25 pounds
• Noise level is typically moderate

Job Title: Senior Quality Auditor

Department: Quality

Reports To: Refer to Syn Cardia Organizational Chart (Quality‑054)

FLSA Status: Exempt