Quality Assurance Manager

Exel Med•Redondo Beach, CA

13d•$145,000 - $165,000•Onsite

About The Position

The Quality Assurance Manager leads, maintains, and continuously improves Exelint International’s Quality Management System (QMS). The role ensures that products, processes, suppliers, and quality systems comply with applicable regulatory requirements, international standards, customer requirements, and internal procedures. It requires hands-on experience with ISO 13485, FDA QMSR, EU MDR, MDSAP, CAPA, audits, supplier quality, complaint handling, and document and change control. The manager serves as a key Quality representative during regulatory and certification audits and works with Regulatory Affairs, Engineering, Operations, Supply Chain, Customer Service, and executive leadership to maintain inspection readiness and promote a strong quality culture. The role oversees QMS processes, audit readiness, investigations and corrective actions, supplier quality, complaint and post-market quality activities, metrics and management reviews, and the development of Quality team members. The position is full-time and onsite.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Quality, Biomedical Sciences, or a related technical discipline.
Minimum 5–7 years of progressive Quality Assurance experience in the medical device, pharmaceutical, biotechnology, or another highly regulated industry.
Prior experience working within a medical device Quality Management System.
Strong working knowledge of ISO 13485 and FDA medical device quality system requirements, including FDA QMSR.
Demonstrated experience with CAPA, nonconformance management, root cause investigation, document control, change control, complaint handling, and internal auditing.
Strong experience participating in and/or leading regulatory, Notified Body, MDSAP, customer, supplier, and certification audits.
Ability to manage audit observations and corrective actions through successful closure.
Strong understanding of risk-based decision-making and quality risk management principles.
Experience developing and analyzing quality metrics and presenting quality system performance to management.
Strong technical writing skills, including drafting and reviewing SOPs, work instructions, investigation reports, CAPAs, audit responses, and other controlled quality documentation.
Strong leadership, organizational, analytical, and problem-solving skills.
Ability to manage multiple priorities and work effectively in a fast-paced, regulated environment.
Ability to balance regulatory compliance with practical business operations and communicate quality and compliance expectations across the organization.

Nice To Haves

Hands-on experience with EU MDR 2017/745, including Quality System requirements supporting MDR compliance and Notified Body audits.
Experience supporting MDSAP audits and regulatory inspections.
Experience with disposable or sterile medical devices, syringes, needles, drug-delivery products, blood collection products, or similar single-use devices.
Experience managing supplier quality programs and contract manufacturers.
Knowledge of ISO 14971 risk management, post-market surveillance, validation, sterilization, packaging, and medical device manufacturing controls.
Experience with electronic Quality Management Systems (eQMS).
Experience working with global suppliers and international regulatory requirements.
ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), RAC, or another relevant regulatory or quality certification.

Responsibilities

Manage, maintain, and continuously improve the QMS in accordance with ISO 13485, FDA QMSR/21 CFR requirements, EU MDR, MDSAP, and other applicable global requirements.
Keep quality procedures, work instructions, forms, records, and supporting documentation current, effective, and compliant.
Oversee document control, change control, training, quality records, nonconformances, deviations, and other core QMS processes.
Evaluate QMS effectiveness using quality metrics, trending, management review inputs, audit results, CAPA effectiveness, and other performance indicators.
Identify systemic quality risks and implement improvements to compliance and operational effectiveness.
Support implementation, administration, and optimization of electronic Quality Management Systems (eQMS).
Lead and support internal, supplier, customer, notified body, MDSAP, and regulatory audits and inspections; maintain continuous audit and inspection readiness.
Develop and execute risk-based internal audit schedules and coordinate front-room and back-room activities during external audits.
Review audit findings, coordinate timely responses, and ensure corrective actions are implemented and verified for effectiveness.
Conduct supplier audits and evaluate supplier quality systems, manufacturing controls, and compliance.
Support remediation related to audit findings, regulatory observations, and quality system gaps.
Lead the CAPA program, including investigation, root cause analysis, corrective action planning, implementation, and effectiveness verification.
Ensure CAPAs are risk-based, documented, completed on time, and supported by objective evidence; guide root cause investigations and problem-solving.
Monitor CAPA and nonconformance trends, identify recurring or systemic issues, and escalate significant quality and compliance risks.
Support EU MDR compliance and partner with Regulatory Affairs on technical documentation, post-market surveillance, risk management, change assessments, and Notified Body activities.
Support quality system requirements for international registrations and global market access, including documentation for MDSAP and other international programs.
Manage supplier qualification, monitoring, audits, corrective actions, quality agreements, and performance evaluations.
Assess supplier changes and quality events for impact on product quality and regulatory compliance; collaborate with Operations and Supply Chain on incoming product and component controls.
Oversee or support receiving inspection, sampling, product inspection, testing, disposition, and applicable validation and qualification activities.
Ensure supplier-related nonconformances and corrective actions are investigated and resolved.
Oversee or support complaint handling and product quality investigations; ensure complaints and quality events are evaluated, investigated, documented, and escalated appropriately.
Partner with Regulatory Affairs on regulatory reporting and post-market surveillance; analyze complaint, nonconformance, supplier, and product quality data for trends and risks.
Support product lifecycle risk management activities.
Develop, monitor, and report quality KPIs and metrics, including CAPA performance, complaints, supplier quality, nonconformances, audit findings, training compliance, and QMS effectiveness.
Prepare Quality Management Review inputs and presentations for executive leadership; communicate significant quality trends, risks, and compliance issues.
Lead, supervise, coach, and develop Quality team members; set responsibilities, priorities, and performance expectations.
Train and guide employees on QMS requirements, procedures, GMP, documentation practices, and quality principles.
Promote accountability, compliance, continuous improvement, and cross-functional collaboration.
Independently identify quality system gaps, develop practical solutions, and drive issues through implementation and effective closure.