Senior Quality Assurance Leader – Medical Devices

Exelint International; Redondo Beach (CA); Presencial; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

Exelint International, a long‑standing medical devices manufacturer and distributor, seeks a Quality Assurance Manager onsite to lead the QMS and drive continuous improvement across the organization.

You will coordinate audits with regulatory bodies, manage CAPA programs, oversee supplier quality, and partner with Regulatory Affairs, Engineering, and Operations to ensure global regulatory compliance and product quality excellence.

Qualificações

• Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Sciences, or a related technical discipline
• Minimum 5–7 years of progressive Quality Assurance experience within a highly regulated industry
• Strong working knowledge of ISO 13485 and FDA medical device quality system requirements, including FDA QMSR
• Experience with CAPA, nonconformance management, root cause investigation, document control, change control, complaint handling, and internal auditing
• Experience participating in and/or leading regulatory, Notified Body, MDSAP, customer, supplier, and certification audits
• Strong leadership, organizational, analytical, and problem-solving skills
• Hands-on experience with electronic Quality Management Systems (eQMS)

Responsabilidades

• Lead and oversee the CAPA program, including investigation, root cause analysis, corrective action planning, implementation, and effectiveness verification
• Ensure CAPAs are risk-based, appropriately documented, completed within established timelines, and supported by objective evidence
• Provide guidance on root cause investigation methodologies and problem-solving tools
• Monitor CAPA and nonconformance trends to identify recurring or systemic quality issues
• Escalate significant quality issues and compliance risks to appropriate leadership
• Manage supplier quality activities, including supplier qualification, monitoring, audits, corrective actions, quality agreements, and performance evaluations
• Collaborate with Operations and Supply Chain to ensure appropriate controls for incoming products and components
• Support regulatory affairs on MDR implementation and regulatory reporting, post-market surveillance, risk management, change assessments, and Notified Body activities
• Develop, monitor, and report meaningful quality KPIs and metrics, including CAPA performance, complaints, supplier quality, nonconformances, audit findings, training compliance, and QMS effectiveness
• Promote a culture of accountability, compliance, continuous improvement, and cross-functional collaboration

Formação académica

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

Descrição da oferta de emprego

Exelint International, a long‑standing medical devices manufacturer and distributor, seeks a Quality Assurance Manager onsite to lead the QMS and drive continuous improvement across the organization.

You will coordinate audits with regulatory bodies, manage CAPA programs, oversee supplier quality, and partner with Regulatory Affairs, Engineering, and Operations to ensure global regulatory compliance and product quality excellence.