Senior QA & Regulatory Excellence Lead

Precision One Medical; Oceanside (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

Precision One Medical in Oceanside, CA is seeking a Sr. Quality Assurance Specialist to lead regulatory and compliance efforts across manufacturing operations and quality systems.

The role collaborates with cross-functional teams to support change management, audit readiness, CAPA, MRB, supplier controls, and documentation control. The ideal candidate has a strong background in ISO 13485 and 21 CFR 820, plus experience with regulatory compliance, audits, and continuous improvement initiatives

Qualifications

• Bachelor's degree with 5+ years of experience
• Master's degree with 2+ years of experience
• ASQ certification preferred (e.g., Quality Engineer, Auditor)

Responsibilities

• Adhere to the Quality Management System to ensure regulatory compliance.
• Support implementation and continuous improvement of the QMS and related regulatory processes.
• Provide regulatory support for manufacturing operations, validation activities, and engineering changes.
• Oversee MRB program to meet regulatory and manufacturing needs.
• Oversee CAPA program to ensure regulatory requirements are met.
• Manage supplier control program including supplier approvals and monitoring.
• Maintain and facilitate the audit program including internal/external audits and follow-up.
• Monitor regulatory requirements and industry standards that impact the business.
• Identify opportunities for continuous improvement in regulatory processes and documentation.
• Lead development and review of quality system procedures and controlled documents.
• Support document control and change management to ensure accuracy and compliance.
• Communicate status updates to senior management and collaborate across departments.
• Perform other duties as assigned.

Skills

ISO 13485

21 CFR Part 820

Part 11

Quality System Regulations ISO 14971

Education

Bachelor's degree

Master's degree

Job description

Precision One Medical in Oceanside, CA is seeking a Sr. Quality Assurance Specialist to lead regulatory and compliance efforts across manufacturing operations and quality systems.

The role collaborates with cross-functional teams to support change management, audit readiness, CAPA, MRB, supplier controls, and documentation control. The ideal candidate has a strong background in ISO 13485 and 21 CFR 820, plus experience with regulatory compliance, audits, and continuous improvement initiatives