Senior QA & Compliance Lead, Medical Devices

Precision One Medical, Inc.; Oceanside (CA); On-site; USD 75,000 - 117,000; Full time

Job summary

Precision One Medical, Inc. is seeking a Sr. Quality Assurance Specialist in Oceanside, CA. The role provides regulatory and compliance leadership for manufacturing operations, quality systems, and regulatory initiatives.

You will collaborate with cross-functional teams to support change management, audit readiness, and continuous improvement while ensuring compliance with ISO13485 and FDA requirements.

Qualifications

• ISO13485 and 21 CFR Part 820/11 knowledge.
• Quality System Regulations ISO 14971 knowledge.
• Ability to adapt to change.
• Independent judgment and discretion.
• Strong written and verbal communication.
• Highly detail-oriented.
• Effective communicator across all levels.
• Computer literacy with standard software.

Responsibilities

• Adhere to the Quality Management System and regulatory requirements.
• Support implementation and improvement of QMS and regulatory processes.
• Oversee MRB, CAPA, supplier control programs.
• Maintain and facilitate the audit program and audit readiness.
• Provide ongoing status updates to senior management.
• Interface and collaborate with other departments and stakeholders.
• Identify opportunities for continuous improvement in regulatory compliance.
• Lead development, maintenance, and review of quality system procedures.

Skills

ISO13485 knowledge

21 CFR Part 820/11 knowledge

Regulatory compliance

Strong communication

Detail-oriented

Independent judgment

Team collaboration

Education

Bachelor’s degree

Master’s degree

Job description

Precision One Medical, Inc. is seeking a Sr. Quality Assurance Specialist in Oceanside, CA. The role provides regulatory and compliance leadership for manufacturing operations, quality systems, and regulatory initiatives.

You will collaborate with cross-functional teams to support change management, audit readiness, and continuous improvement while ensuring compliance with ISO13485 and FDA requirements.