Quality Manager: Regulatory & Quality Systems Focused

Columbus, OH, USA|Onsite

Job Overview

Employment Type

Full-time

Compensation

Salary

Range $120,000.00 - $140,000.00

Work Schedule

Standard Hours

Benefits

Health Insurance

Dental Insurance

Paid Time Off

Retirement Plan

Professional Development

performance bonuses

Employee wellness programs

Job Description

American Nitrile is a leading manufacturer specializing in high-quality medical gloves designed to meet stringent safety and performance standards. As an innovative and customer-focused company, American Nitrile is committed to ensuring their products meet or exceed regulatory requirements globally. Operating within the medical device manufacturing sector, American Nitrile emphasizes compliance, quality, and continuous improvement in all aspects of its production and business operations. The company is well integrated into the healthcare supply chain, and its focus on regulatory and quality excellence helps protect patient safety and supports healthcare providers worldwide.

The role of Quality Manager - Quality Systems & Regulatory Manager at American Nitrile is pivotal to maintaining this commitment. This position involves the development, implementation, and continuous enhancement of the Quality Management System (QMS) and Regulatory Compliance programs specific to medical gloves. The manager will ensure all products, including nitrile medical gloves, are designed, manufactured, tested, and distributed according to applicable regulations such as FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ASTM standards like D6319 and D6978, and other international regulatory frameworks. This is a full-time, leadership role that requires a minimum of seven years of relevant experience, with competitive compensation reflective of the specialized skills required.

In this capacity, the Quality Manager serves as the site subject matter expert for regulatory compliance and quality assurance, working closely with various operational teams. Responsibilities include overseeing the entire QMS, managing regulatory affairs including submissions and compliance with FDA 510(k) and global registrations, and leading quality event management efforts such as CAPAs, non-conformances, and change controls. This position also involves managing post-market surveillance activities and supplier quality assurance in alignment with customer and regulatory expectations.

The role requires the ability to coordinate internal and external audits, prepare for FDA and ISO inspections, and maintain high standards for documentation control, validation, and process control. This manager will lead management review meetings and ensure all personnel are adequately trained to uphold quality and regulatory standards. Expertise in risk management under ISO 14971 is also essential to integrate risk assessments into design and manufacturing.

Ultimately, this position demands a collaborative leader who can partner with operations, engineering, R&D, and supply chain departments to embed quality and compliance at every stage of the product lifecycle. The Quality Manager will contribute to sustaining an audit-ready environment, utilizing advanced QMS software tools and driving data-driven decision-making. This role combines technical regulatory knowledge with strategic organizational leadership to uphold the safety, efficacy, and market success of American Nitrile's medical glove products.

Job Requirements

Bachelor’s degree in engineering, life sciences, regulatory affairs or related field
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), ISO 13485, ASTM standards for medical gloves, and cGMP requirements
Experience with FDA 510(k) submissions and regulatory compliance for Class I/II devices
Understanding of product testing requirements such as AQL, barrier integrity, tensile strength, chemical resistance
Strong analytical and problem-solving skills
Demonstrated expertise in CAPA systems, audits, and compliance management
Ability to interpret complex regulations and translate into operational processes
Strong leadership, communication, and organizational skills
Experience with QMS software
Proficient in Microsoft Office Suite
Experience supporting FDA inspections and regulatory body interactions

Job Qualifications

Bachelor’s degree in engineering, life sciences, regulatory affairs or related field
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), ISO 13485, ASTM standards for medical gloves (D6319, D6978), and cGMP requirements for medical devices
Experience with FDA 510(k) submissions and regulatory compliance for Class I/II devices
Understanding of product testing requirements including AQL, barrier integrity, tensile strength, and 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
ASQ Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or equivalent preferred
Regulatory Affairs Certification (RAC) is a plus
Experience with QMS software such as Greenlight Guru or similar
Proficient in Microsoft Office Suite (Word, Excel, Outlook)
Experience supporting FDA inspections and interactions with international regulatory bodies
Proven success in maintaining audit-ready state

Job Duties

Maintain and continuously improve the quality management system in compliance with FDA, ISO 13485, and international standards
Ensure alignment of processes with glove-specific requirements including biocompatibility, barrier performance, and sterility
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
Manage customer complaints, medical device reporting where applicable, and post-market surveillance programs
Qualify and monitor suppliers of raw materials and packaging components
Lead supplier audits and ensure supplier compliance with quality requirements
Lead internal audit program and host external audits
Ensure site readiness for regulatory inspections and coordinate responses to audit findings
Oversee document control systems ensuring accurate and compliant documentation
Review and approve SOPs, work instructions, forms, specifications, and validation documents
Ensure validation of manufacturing processes 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 and ensure training compliance across the organization
Develop and deliver regulatory and quality training programs
Implement and maintain risk management processes according to ISO 14971
Partner with operations, engineering, R&D, and supply chain to embed quality and regulatory requirements in all processes