POSITION SUMMARY
The Quality Assurance Manager is responsible for leading the site's Quality Assurance and Regulatory Compliance functions, ensuring Aptyx Charlotte maintains compliance with applicable U.S. FDA requirements, international medical device regulations, and relevant industry standards. This role provides strategic direction and operational oversight of the Quality Management System (QMS), regulatory compliance, product quality, supplier quality, and audit readiness to ensure safe, effective, and compliant products are delivered to customers.
Working in a contract product development and manufacturing environment, this position partners closely with Research & Development (R&D), Engineering, Program Management, Operations, and other cross-functional teams to support medical device development from concept through commercialization and production. Products include disposable medical devices such as catheters, catheter-based delivery systems, and other devices supporting clinical disciplines including cardiology, neurology, and urology.
The Quality Assurance Manager serves as the site's Management Representative, providing leadership and oversight of quality systems, regulatory activities, customer and supplier quality requirements, and continuous improvement initiatives. This position leads the Quality team, develops departmental capabilities, and drives a culture of quality, accountability, and continuous improvement throughout the organization.
DUTIES AND RESPONSIBILITIES
Quality Leadership & Regulatory Compliance
- Develop and execute the site's quality and regulatory strategies in alignment with business objectives, customer requirements, and applicable regulatory standards.
- Maintain, implement, and continuously improve the Quality Management System to ensure compliance with applicable FDA regulations, ISO 13485, ISO 14971, and international medical device requirements.
- Serve as the site's Management Representative, fulfilling applicable responsibilities outlined in the Management Responsibility Procedure (003816).
- Maintain FDA site establishment registration and support ongoing ISO 13485 certification.
- Serve as the primary site liaison with regulatory agencies, including the FDA, and coordinate timely responses to regulatory inquiries and customer requests.
- Ensure appropriate systems, procedures, and controls are established for product acceptance, final inspection, and lot release.
- Oversee process, equipment, and facility qualification and validation programs.
- Ensure appropriate controls are maintained for calibration, metrology, environmental monitoring, and other applicable quality systems.
- Oversee supplier and supply chain quality, including raw materials, external service providers, and sterilization processes.
- Ensure compliance with applicable Customer Quality Agreements and Supplier Quality Agreements.
Audit Management & Continuous Improvement
- Lead and support external regulatory, customer, and certification audits, including preparation, execution, responses, and corrective action follow-up.
- Serve as Lead Auditor for the internal audit program, ensuring audits are conducted effectively and in accordance with regulatory and QMS requirements.
- Champion the annual Management Review process, ensuring required inputs, outputs, and follow-up actions are completed.
- Direct and oversee the Material Review Board (MRB), customer complaint, nonconformance, and Corrective and Preventive Action (CAPA) systems.
- Apply structured problem-solving and root cause analysis methodologies to identify, investigate, communicate, and resolve quality issues.
- Identify opportunities to improve quality systems, processes, and operational performance.
R&D and New Product Development Support
- Provide quality and regulatory leadership throughout product development, from concept through design transfer and production.
- Partner with R&D and Engineering leaders to establish and implement appropriate design controls based on risk management, customer requirements, and manufacturability.
- Ensure design inputs, outputs, reviews, verification, and validation activities are appropriately documented and compliant with QMS requirements.
- Develop, maintain, and review Design History Files (DHF) on behalf of customers.
- Lead and contribute to risk management activities in accordance with ISO 14971.
- Review technical documentation, protocols, test reports, and quality records to ensure compliance with applicable requirements.
- Support the development and optimization of inspection procedures, sampling plans, and quality control methods based on critical design attributes, risk, and statistical rationale.
- Ensure appropriate measurement and metrology methods are established and utilized.
- Monitor customer regulatory submissions, compliance inquiries, and audit findings, communicating relevant lessons learned and supporting responses to product and quality system-related questions.
Department & People Leadership
- Lead, develop, and manage the Quality department, ensuring appropriate staffing, resource allocation, workload management, and employee development.
- Partner with R&D and other functional leaders to ensure quality resources are appropriately deployed across development projects and operational priorities.
- Establish departmental objectives, performance expectations, and Key Performance Indicators (KPIs).
- Provide ongoing coaching, mentoring, and feedback to direct reports through regular performance discussions and formal performance reviews.
- Support employee engagement, accountability, and professional development within the Quality organization.
- Manage the recruitment, selection, and onboarding of Quality personnel in accordance with company policies.
- Address employee performance and disciplinary matters in partnership with Human Resources.
- Provide guidance and training to employees throughout the organization regarding internal quality procedures, regulatory standards, and customer requirements.
Customer & Cross-Functional Partnership
- Partner with customers and internal stakeholders to address quality concerns, escalations, and regulatory requirements while maintaining strong customer relationships.
- Ensure customer quality commitments and contractual quality requirements are understood and fulfilled.
- Collaborate with Operations, Engineering, R&D, Program Management, and Supply Chain to ensure quality is integrated into business and project decisions.
- Provide quality resources, technical guidance, and regulatory expertise to support organizational objectives.
- Communicate departmental performance, significant quality issues, risks, and improvement initiatives to site leadership.
QUALIFICATIONS
- Demonstrated leadership experience with the ability to lead teams, manage competing priorities, and drive results in a dynamic environment.
- Proven ability to establish and promote a culture of quality, accountability, employee engagement, and continuous improvement.
- Mandatory medical device quality experience, including involvement in complex product development and manufacturing projects.
- Certified ISO 13485 Lead Auditor or equivalent recognized auditor certification.
- Six Sigma Black Belt certification preferred.
- Demonstrated ability to influence and collaborate with cross-functional teams and senior leadership.
EDUCATION
- Bachelor's degree in Engineering or a related technical discipline, or equivalent combination of education and relevant experience.
EXPERIENCE
- Minimum of five years of Quality Engineering or Quality Assurance experience within the medical device industry.
- Experience supporting new product development and design control activities preferred.
- Experience with ISO quality management systems and FDA-regulated environments.
- Demonstrated experience leading quality assessments, internal audits, external audits, and regulatory inspections.
- Experience developing, implementing, and maintaining Quality Management Systems.
- Experience with Design History Files, risk management, verification, and validation activities.
- Previous experience supervising, developing, and managing employees preferred.
- Experience in a contract product development and manufacturing environment preferred.
SKILLS, KNOWLEDGE & ABILITIES
- Strong working knowledge of ISO 13485, ISO 14971, and applicable FDA medical device regulations, including 21 CFR Part 820.
- Knowledge of international medical device regulatory requirements and quality standards.
- Technical understanding of disposable medical device testing, protocols, data analysis, and technical report writing.
- Knowledge of statistical methods, including Statistical Process Control (SPC), Design of Experiments (DOE), and sampling methodologies.
- Strong analytical, investigative, and problem-solving capabilities.
- Demonstrated ability to lead teams, influence stakeholders, and effectively manage resources.
- Excellent written, verbal, presentation, and interpersonal communication skills.
- Strong organizational skills with the ability to prioritize, manage multiple initiatives, and meet business objectives.
- Proficiency in Microsoft Office and applicable quality management systems.
- Ability to work independently while fostering collaboration and teamwork.
REGULATORY & QUALITY REQUIREMENTS
- Ensure ongoing compliance with applicable U.S. FDA and international medical device regulations and industry standards.
- Maintain the site's ISO 13485 certification and associated Quality Management System.
- Maintain FDA site establishment registration.
- Ensure implementation and compliance with ISO 14971 risk management requirements.
- Maintain audit readiness and ensure timely resolution of identified quality and regulatory findings.
- Ensure appropriate quality controls are maintained throughout product development, manufacturing, and product release.
Acknowledgement
I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.
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