The purpose of the Quality Manager - Quality Systems & Regulatory Manager is to develop, implement, maintain, and continuously improve the Quality Management System (QMS) and Regulatory Compliance programs at American Nitrile. This role ensures all medical glove products are designed, manufactured, tested, and distributed in compliance with applicable regulatory requirements, including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ASTM standards (e.g., D6319, D6978), and other global regulatory requirements, while meeting customer expectations for safety, quality, and performance.
Duties and responsibilities
The Quality Systems & Regulatory Manager is responsible for the management, compliance, and continuous improvement of both Quality Systems and Regulatory Affairs functions. This individual serves as the site subject matter expert for regulatory compliance and quality assurance.
Primary duties and responsibilities include:
· Quality Management System (QMS) Oversight
o Maintain and continuously improve the QMS in compliance with FDA, ISO 13485, and applicable international standards.
o Ensure alignment of processes with glove-specific requirements, including biocompatibility, barrier performance, and sterility (if applicable).
· Regulatory Affairs Management
o Interpret and implement regulatory requirements for medical gloves, including FDA 510(k), product listings, and technical files.
o Maintain regulatory submissions, registrations, and licenses in applicable markets.
o Monitor changes to global regulatory requirements and ensure organizational compliance.
· Quality Event Management
o Oversee investigations, CAPAs, non-conformances, deviations, and change controls.
o Ensure root cause analysis is robust, timely, and effective, with sustainable corrective actions.
· Complaint Handling & Post-Market Surveillance
o Manage customer complaints, Medical Device Reporting (MDR) where applicable, and post-market surveillance programs.
o Trend complaint data and identify systemic quality issues.
· Supplier Quality Management
o Qualify and monitor suppliers of raw materials (e.g., nitrile, chemicals) and packaging components.
o Lead supplier audits and ensure supplier compliance with quality requirements.
· Audit & Inspection Readiness
o Lead internal audit program and host external audits (FDA, ISO registrars, customers).
o Ensure site readiness for regulatory inspections and coordinate responses to audit findings.
· Documentation Control
o Oversee document control systems, ensuring accurate, current, and compliant documentation.
o Review and approve SOPs, Work Instructions, Forms, Specifications, and Validation documents.
· Validation & Process Control
o Ensure validation of manufacturing processes (e.g., dipping, curing, stripping) and test methods.
o Support statistical process control and process capability analysis.
· Management Review & Metrics
o Prepare and present quality and regulatory performance metrics.
o Facilitate management review meetings, including agenda preparation, reporting, and follow-up actions.
· Training & Compliance
o Manage Learning Management System (LMS) and ensure training compliance across the organization.
o Develop and deliver regulatory and quality training programs.
· Risk Management
o Implement and maintain risk management processes in accordance with ISO 14971.
o Ensure risk assessments are integrated into design, manufacturing, and change control processes.
· Cross-Functional Collaboration
o Partner with Operations, Engineering, R&D, and Supply Chain to ensure quality and regulatory requirements are embedded in all processes.
Qualifications
Education:
- Bachelor’s Degree (B.A. or B.S.) in Engineering, Life Sciences, Regulatory Affairs, or related field (Master’s preferred).
Experience:
- Minimum of 7 years of experience in Quality Systems and/or Regulatory Affairs within a regulated medical device manufacturing environment.
- Minimum of 5 years in a leadership or management role.
Technical Knowledge:
- Strong knowledge of:
- 21 CFR Part 820 (FDA QSR)
- ISO 13485
- ASTM standards for medical gloves (e.g., D6319, D6978)
- cGMP requirements for medical devices
- Experience with FDA 510(k) submissions and regulatory compliance for Class I/II devices.
- Understanding of product testing requirements (e.g., AQL, barrier integrity, tensile strength, chemical resistance).
Skills & Competencies:
- Strong analytical and problem-solving skills with data-driven decision-making.
- Demonstrated expertise in CAPA systems, audits, and compliance management.
- Ability to interpret complex regulations and translate them into operational processes.
- Strong leadership, communication, and organizational skills.
Certifications (preferred):
- ASQ Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or equivalent.
- Regulatory Affairs Certification (RAC) is a plus.
Systems & Tools:
- Experience with QMS software (e.g., Greenlight Guru or similar).
- Proficient in Microsoft Office Suite (Word, Excel, Outlook).
Regulatory Experience:
- Experience supporting FDA inspections and interactions with international regulatory bodies.
- Proven success in maintaining audit-ready state.
Working conditions
This position operates in both office and manufacturing environments. The role requires regular presence on the production floor to audit processes, support investigations, and ensure compliance. The employee may be required to stand or sit for extended periods and must adhere to all personal protective equipment (PPE) requirements based on assigned tasks.
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