Job Description

Job Summary:

Quality Coordinator - Change Control, Document Control and Training – is responsible for overseeing all product changes, document changes, and training to documents to ensure continuous improvement of core Quality System elements within a regulated medical device environment. This role ensures compliance with FDA 21 CFR Part 820, ISO 13485:2016, and other applicable regulations by managing robust change control processes, secure and compliant document control systems, and an effective training program that supports a state of inspection readiness across the organization.

MasterControl is the electronic Quality Management System (eQMS) utilized; prior experience with MasterControl is strongly preferred.

Essential Duties and Responsibilities:

• Own and manage the Change Control process, including intake, evaluation, coordination of impact assessments, approvals, implementation tracking, and closure.
• Assist the Quality Manager in Change Control Review Board (CCRB) meetings and ensure changes are executed in compliance with regulatory and internal requirements.
• Maintain and Improve the Document Control system to ensure proper creation, review, approval, distribution, and archiving of controlled documents.
• Administer the Training Program, including onboarding, role-based training assignments, compliance tracking, and ongoing curriculum updates.
• Utilize the MasterControl electronic Quality Management System to manage workflows, maintain data integrity, and support audit-readiness.
• Develop and maintain procedures, work instructions, and training materials related to change control, document control, and training.
• Generate and analyze quality system metrics and KPIs to drive continuous improvement
• Support internal and external audits, regulatory inspections, and CAPA activities related to document, change, and training systems.
• Collaborate with functional stakeholders (e.g., Regulatory, Operations, Supply Chain, HR etc.) to align documentation and training efforts with business objectives.
• Coordinate and manage Quality System requests and documentation needs from the Custom Manufacturing Division, ensuring alignment with established QMS processes and timelines.

Education, Certifications and/or Work Experience Requirements:

• Bachelor’s degree in Life Sciences, Engineering, Quality Systems, Regulatory Affairs, or a related field required.
• Minimum of 3-5 years experience in Quality Assurance or Quality Systems within the medical device, pharmaceutical, or other regulated industry.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971.
• Experience using an electronic Quality Management System (eQMS) is required; MasterControl experience is strongly preferred.
• Demonstrated ability to manage quality system processes such as change control, document control, and training in a cross-functional environment.

Skills/Knowledge Requirements:

• Excellent computer proficiency (MS Office – Word, Excel, and Outlook)
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
• Proficiency in managing and optimizing electronic Quality Management Systems (eQMS); MasterControl experience preferred.
• Relevant certifications such as ASQ Certified Quality Auditor or ISO 13485:2016 Lead Auditor are a plus.

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