Quality Coordinator

NIPRO Corporation - Global; Bridgewater (MA); On-site; USD 69,800 - 83,045; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading medical device company in Bridgewater is seeking a Quality Coordinator to manage change control, document management, and training programs. The role requires a Bachelor’s degree and 3-5 years of experience in Quality Assurance. Responsibilities include ensuring compliance with FDA regulations and managing quality systems. Candidates should have experience with MasterControl and possess strong communication skills. This position is full-time with competitive compensation.

Qualifications

• 3-5 years experience in Quality Assurance or Quality Systems within a regulated industry.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485:2016.
• Experience using an eQMS is required.

Responsibilities

• Manage the Change Control process including intake and implementation tracking.
• Maintain and improve the Document Control system for proper document management.
• Administer the Training Program and ensure compliance tracking.

Skills

Computer proficiency (MS Office)

Verbal and written communication

Ability to work under pressure

Independent work capability

Management of electronic Quality Management Systems

Education

Bachelor’s degree in Life Sciences, Engineering, Quality Systems, Regulatory Affairs

Tools

MasterControl

Job description

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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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Training

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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