Senior QA Manager – Medical Devices & Compliance

Exelint International; Redondo Beach (CA); On-site; USD 129,000 - 146,000; Full time

Job summary

Exelint International, based in Redondo Beach, CA, seeks a Quality Assurance Manager to lead the QMS and ensure compliance with ISO 13485, FDA QMSR, EU MDR, and MDSAP. This onsite role partners with Regulatory Affairs, Engineering, Operations, and Supply Chain to sustain regulatory readiness and a culture of quality.

The successful candidate has 5–7 years in regulated QA, strong auditing, CAPA, document/control processes, and leadership to drive continuous improvement across the organization.

Qualifications

• Bachelor's degree in a related technical field.
• 5–7 years of progressive QA experience in regulated industry.
• Knowledge of ISO 13485 and FDA QMSR requirements.
• Experience with CAPA, nonconformance, root cause, document/change control, complaint handling, and internal auditing.
• Experience leading regulatory, Notified Body, MDSAP, customer, supplier, and certification audits.
• Strong risk-based decision making and quality risk management.
• Experience developing and presenting quality metrics and SOPs.

Responsibilities

• Lead and maintain the QMS per ISO 13485 and FDA QMSR requirements.
• Lead internal, supplier, customer, notified body, MDSAP, and regulatory audits and inspections.
• Oversee CAPA program, root cause investigations, and corrective actions.
• Support EU MDR compliance and global regulatory quality activities.
• Manage supplier quality and manufacturing oversight.
• Oversee complaints, post-market and product quality activities.
• Develop quality metrics and management review materials.
• Lead and develop the Quality team and promote cross-functional collaboration.

Skills

Auditing

CAPA

Quality leadership

Regulatory compliance

Document control

Supplier quality

Root cause analysis

GMP/ISO knowledge

Education

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

Tools

eQMS systems

Job description

Exelint International, based in Redondo Beach, CA, seeks a Quality Assurance Manager to lead the QMS and ensure compliance with ISO 13485, FDA QMSR, EU MDR, and MDSAP. This onsite role partners with Regulatory Affairs, Engineering, Operations, and Supply Chain to sustain regulatory readiness and a culture of quality.

The successful candidate has 5–7 years in regulated QA, strong auditing, CAPA, document/control processes, and leadership to drive continuous improvement across the organization.