Senior FDA Quality & Compliance Manager

Inquis Medical, Inc.; San Francisco (CA); On-site; USD 145,000 - 165,000; Full time

Job summary

Inquis Medical, Inc. is seeking a quality/regulatory lead to ensure the company’s quality system complies with California FDB and US FDA QSR requirements. You may initiate CAPAs, drive corrective actions, and coordinate with suppliers and internal departments to prevent non-conformities.

You will establish and maintain the QMS, review regulatory requirements, manage audits and MRB, and ensure proper labeling, change control, and calibration across production and R&D instruments.

Qualifications

• Bachelor's degree in engineering or related field is required.
• Familiarity with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
• Experience in medical device startups is preferred.
• Minimum 6 years of quality experience in FDA-regulated medical devices or related industry.
• Experience in managing sterilization controls for a Class II or Class III sterile product (EO preferred).

Responsibilities

• Establish and maintain Quality Management System (QMS).
• Review and interpret regulatory requirements; implement via policies and procedures.
• Prepare and review FDA regulatory applications and documents (e.g., 510k submissions).
• Review manufacturing processes for FDA/FDB compliance.
• Manage supplier quality management/audit program and internal quality audits.
• Lead CAPA/NCR systems and MRB as required.
• Ensure training on QMS procedures and calibration of instruments.

Skills

Regulatory compliance understanding

Quality management systems

CAPA/NCR process knowledge

Document control

Supplier quality management

Education

Bachelor's degree in engineering or related field

FDA/regulatory knowledge (21 CFR 820, Part 11)

ISO 13485 / ISO 14971 familiarity

6+ years quality experience in FDA-regulated devices

Job description

Inquis Medical, Inc. is seeking a quality/regulatory lead to ensure the company’s quality system complies with California FDB and US FDA QSR requirements. You may initiate CAPAs, drive corrective actions, and coordinate with suppliers and internal departments to prevent non-conformities.

You will establish and maintain the QMS, review regulatory requirements, manage audits and MRB, and ensure proper labeling, change control, and calibration across production and R&D instruments.