Quality Manager: Regulatory & Quality Systems Focused

Available Jobs•Grove City, OH

9d•Hybrid

About The Position

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.

Requirements

Bachelor’s Degree (B.A. or B.S.) in Engineering, Life Sciences, Regulatory Affairs, or related field (Master’s preferred).
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.
Strong knowledge of: 21 CFR Part 820 (FDA QSR)
Strong knowledge of: ISO 13485
Strong knowledge of: ASTM standards for medical gloves (e.g., D6319, D6978)
Strong knowledge of: 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).
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.
Experience supporting FDA inspections and interactions with international regulatory bodies.
Proven success in maintaining audit-ready state.
Proficient in Microsoft Office Suite (Word, Excel, Outlook).

Nice To Haves

Master’s degree
ASQ Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or equivalent.
Regulatory Affairs Certification (RAC) is a plus.
Experience with QMS software (e.g., Greenlight Guru or similar).

Responsibilities

Maintain and continuously improve the QMS in compliance with FDA, ISO 13485, and applicable international standards.
Ensure alignment of processes with glove-specific requirements, including biocompatibility, barrier performance, and sterility (if applicable).
Interpret and implement regulatory requirements for medical gloves, including FDA 510(k), product listings, and technical files.
Maintain regulatory submissions, registrations, and licenses in applicable markets.
Monitor changes to global regulatory requirements and ensure organizational compliance.
Oversee investigations, CAPAs, non-conformances, deviations, and change controls.
Ensure root cause analysis is robust, timely, and effective, with sustainable corrective actions.
Manage customer complaints, Medical Device Reporting (MDR) where applicable, and post-market surveillance programs.
Trend complaint data and identify systemic quality issues.
Qualify and monitor suppliers of raw materials (e.g., nitrile, chemicals) and packaging components.
Lead supplier audits and ensure supplier compliance with quality requirements.
Lead internal audit program and host external audits (FDA, ISO registrars, customers).
Ensure site readiness for regulatory inspections and coordinate responses to audit findings.
Oversee document control systems, ensuring accurate, current, and compliant documentation.
Review and approve SOPs, Work Instructions, Forms, Specifications, and Validation documents.
Ensure validation of manufacturing processes (e.g., dipping, curing, stripping) and test methods.
Support statistical process control and process capability analysis.
Prepare and present quality and regulatory performance metrics.
Facilitate management review meetings, including agenda preparation, reporting, and follow-up actions.
Manage Learning Management System (LMS) and ensure training compliance across the organization.
Develop and deliver regulatory and quality training programs.
Implement and maintain risk management processes in accordance with ISO 14971.
Ensure risk assessments are integrated into design, manufacturing, and change control processes.
Partner with Operations, Engineering, R&D, and Supply Chain to ensure quality and regulatory requirements are embedded in all processes.