Quality Assurance Manager

Company DescriptionExelint International is a long-established manufacturer and distributor of single-use medical products, including disposable delivery sharps, drug delivery devices, syringes, needles, and blood collection products. For over 40 years, the company has served healthcare providers with reliable medical devices designed to support safety, efficiency, and positive clinical outcomes.Exelint operates in a highly regulated environment and maintains rigorous quality standards throughout its product portfolio and global supply chain. Our team is committed to regulatory compliance, product quality, patient safety, and continuous improvement.Quality Assurance ManagerFull-Time, OnsiteIndustry: Medical DevicesSummary:The Quality Assurance Manager is responsible for the day-to-day leadership, maintenance, and continuous improvement of Exelint International's Quality Management System (QMS). This position ensures that products, processes, suppliers, and quality systems comply with applicable regulatory requirements, international standards, customer requirements, and internal procedures.The Quality Assurance Manager will have strong hands-on experience with ISO 13485, FDA Quality Management System Regulation (QMSR), EU MDR, MDSAP, CAPA, internal and external auditing, supplier quality, complaint handling, and document/change control.This role serves as a key Quality representative during regulatory and certification audits and works closely with Regulatory Affairs, Engineering, Operations, Supply Chain, and executive leadership to maintain inspection readiness and drive a strong culture of quality throughout the organization.Key Responsibilities:Quality Management System (QMS)

• Manage, maintain, and continuously improve the company's Quality Management System in accordance with ISO 13485, FDA QMSR/21 CFR requirements, EU MDR, MDSAP, and other applicable global regulatory requirements.
• Ensure quality procedures, work instructions, forms, records, and supporting documentation remain current, effective, and compliant.
• Oversee document control, change control, training, quality records, nonconformances, deviations, and other core QMS processes.
• Evaluate QMS effectiveness through quality metrics, trending, management review inputs, audit results, CAPA effectiveness, and other performance indicators.
• Identify systemic quality risks and implement improvements to strengthen compliance and operational effectiveness.
• Support the implementation, administration, and optimization of electronic Quality Management Systems (eQMS).

Audits & Inspection Readiness

• Lead and support internal, supplier, customer, notified body, MDSAP, and regulatory audits and inspections.
• Maintain a state of continuous audit and inspection readiness across the organization.
• Develop and execute risk-based internal audit schedules in accordance with applicable regulatory and quality system requirements.
• Serve as a key Quality representative during external audits and coordinate front-room and back-room audit activities.
• Review audit observations and findings, coordinate timely responses, and ensure corrective actions are appropriately implemented and verified for effectiveness.
• Conduct supplier audits and evaluate supplier quality systems, manufacturing controls, and compliance.
• Support remediation activities associated with audit findings, regulatory observations, and identified quality system gaps.

CAPA, Nonconformance & Root Cause Investigation

• 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.

EU MDR & Global Regulatory Quality Support

• Support continued compliance with EU Medical Device Regulation (EU MDR 2017/745) and applicable quality system requirements.
• Partner closely with Regulatory Affairs on MDR implementation and maintenance activities, including technical documentation, post-market surveillance, risk management, change assessments, and Notified Body activities.
• Support quality system requirements associated with international registrations and global market access.
• Ensure QMS processes appropriately support regulatory commitments and product lifecycle requirements.
• Support preparation and maintenance of documentation required for MDSAP and other international regulatory programs.

Supplier Quality & Manufacturing Oversight

• Manage supplier quality activities, including supplier qualification, monitoring, audits, corrective actions, quality agreements, and performance evaluations.
• Assess supplier changes and quality events for potential impact to product quality and regulatory compliance.
• Collaborate with Operations and Supply Chain to ensure appropriate controls are established for incoming products and components.
• Oversee or support receiving inspection, sampling, product inspection, testing, and disposition activities.
• Support validation and qualification activities where appropriate, including manufacturing, packaging, sterilization, and inspection processes.
• Ensure supplier-related nonconformances and corrective actions are appropriately investigated and resolved.
• Complaints, Post-Market & Product Quality
• 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 to support regulatory reporting and post-market surveillance requirements.
• Analyze complaint, nonconformance, supplier, and product quality data to identify trends and emerging risks.
• Support risk management activities throughout the product lifecycle.
• Quality Metrics & Management Review
• Develop, monitor, and report meaningful quality KPIs and metrics, including CAPA performance, complaints, supplier quality, nonconformances, audit findings, training compliance, and QMS effectiveness.
• Perform quality data trending and identify opportunities for corrective action and continuous improvement.
• Prepare Quality Management Review inputs and presentations for executive leadership.
• Communicate significant quality trends, risks, and compliance issues clearly and proactively.
• Leadership & Team Development
• Lead, supervise, coach, and develop Quality team members.
• Establish clear responsibilities, priorities, and performance expectations for the Quality function.
• Provide training and guidance to employees on QMS requirements, procedures, GMP, documentation practices, and quality principles.
• Promote a culture of accountability, compliance, continuous improvement, and cross-functional collaboration.
• Partner effectively with Regulatory Affairs, Engineering, Operations, Supply Chain, Customer Service, and executive leadership.

QualificationsRequired

• 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 the medical device, pharmaceutical, biotechnology, or other 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.
• Demonstrated 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 with experience 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.

Strongly Preferred

• 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 medical devices, 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.

Preferred CertificationsProfessional quality certifications are highly desirable, including:

• ASQ Certified Quality Auditor (CQA)
• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
• RAC or other relevant regulatory/quality certifications

Skills & CompetenciesThe successful candidate will demonstrate strong ownership of the Quality function and the ability to balance regulatory compliance with practical business operations. Key competencies include strong auditing capability, sound quality judgment, attention to detail, effective root cause analysis, technical writing, data-driven decision-making, leadership, and the ability to communicate quality and compliance expectations across all levels of the organization.This position requires an individual who is comfortable operating in a hands-on environment, independently identifying quality system gaps, developing practical solutions, and driving issues through implementation and effective closure.

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