Senior Quality Manager - Medical Devices (ISO 13485)

Halma plc; Vista (CA); On-site; USD 130,000 - 160,000; Full time

Job summary

Surgistar, located in Vista, California, is seeking a Sr. Quality Manager to lead QA/RA efforts in a medical device environment. This role reports to the Sr. Director, Plant Operations/GM and sits in the Quality department.

The successful candidate will oversee QMS, regulatory filings, CAPA, and cross‑functional collaboration with Manufacturing, R&D, Engineering, and Supply Chain to improve product quality and compliance. Compensation reflects market standards.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 6 to 10 years of progressive QA/RA experience in a regulated manufacturing environment (medical device, pharma, biotech).
• 2+ years of supervisory or team management experience.
• Deep knowledge of cGMP, FDA regulations, ISO standards, and risk management tools (FMEA, root-cause analysis).

Responsibilities

• Implement, maintain, and improve the QMS to align with ISO 13485.
• Oversee day-to-day quality control processes, batch record reviews, and final product release.
• Manage Corrective and Preventive Actions (CAPA), nonconformances, and customer/internal complaints.
• Support regulatory filings, registrations, and product submissions (510(k) clearances for medical devices).
• Act as the primary liaison for external regulatory bodies, auditors, and client inspections (FDA, ISO registrars).
• Lead, mentor, and develop the quality team; track and present quality metrics to leadership.

Skills

QA/RA leadership

Regulatory compliance

FMEA

Root-cause analysis

cGMP knowledge

FDA regulations

ISO standards

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Job description

Surgistar, located in Vista, California, is seeking a Sr. Quality Manager to lead QA/RA efforts in a medical device environment. This role reports to the Sr. Director, Plant Operations/GM and sits in the Quality department.

The successful candidate will oversee QMS, regulatory filings, CAPA, and cross‑functional collaboration with Manufacturing, R&D, Engineering, and Supply Chain to improve product quality and compliance. Compensation reflects market standards.