Onsite Senior QA Manager, Medical Devices | ISO 13485 Lead

Exel Med; Redondo Beach (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Exelint International is seeking a Quality Assurance Manager to lead the day-to-day operation and continuous improvement of the company’s QMS. This onsite role partners with Regulatory Affairs, Engineering, Operations, and Supply Chain to ensure compliance with ISO 13485, QMSR, EU MDR, and MDSAP, driving a culture of quality across the organization.

The ideal candidate has hands-on experience with CAPA, audits, document control, and quality metrics, and willmentor a growing Quality team while

Qualifications

• Bachelor's degree in engineering, life sciences, quality, or related technical discipline.
• Minimum 5-7 years of progressive QA experience in medical devices or regulated industry.
• Experience with ISO 13485 and FDA QMSR requirements.
• Proven CAPA, nonconformance, root cause investigation, and document/control management.
• Strong internal and external auditing experience.
• Ability to lead risk-based decision making and quality risk management.
• Excellent technical writing and leadership skills.

Responsibilities

• Lead the QMS maintenance and continuous improvement per ISO 13485 and global regs.
• Oversee CAPA, nonconformances, deviations, and change control activities.
• Coordinate internal, supplier, Notified Body, MDSAP, and regulatory audits.
• Maintain audit readiness and manage audit responses and corrective actions.
• Lead supplier quality assessments and manufacturing oversight.
• Develop and report quality KPIs and drive corrective actions.

Skills

ISO 13485

FDA QMSR

CAPA

Audit leadership

Root cause

Documentation control

Change control

Quality metrics

Technical writing

Leadership

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Sciences, or related

Tools

eQMS

Job description

Exelint International is seeking a Quality Assurance Manager to lead the day-to-day operation and continuous improvement of the company’s QMS. This onsite role partners with Regulatory Affairs, Engineering, Operations, and Supply Chain to ensure compliance with ISO 13485, QMSR, EU MDR, and MDSAP, driving a culture of quality across the organization.

The ideal candidate has hands-on experience with CAPA, audits, document control, and quality metrics, and willmentor a growing Quality team while