Product Quality Associate

Nipro Medical is seeking a detail-oriented Product Quality Associate to support our Quality Management System (QMS) and ensure the consistent release of high-quality, compliant products. This role is responsible for oversight of document control processes, finished product batch record review and release, and reconciliation of product components.

The ideal candidate will help ensure production and quality records are accurate, complete, and compliant with regulatory and company standards, while contributing to continuous improvement initiatives in alignment with FDA QMSR/21 CFR Part 820 and ISO 13485.

• Maintain and oversee document control processes within the Quality Management System
• Perform detailed review and release of finished product batch records to ensure completeness, accuracy, and compliance
• Reconcile product components and verify production documentation
• Ensure all production and quality records meet internal standards and regulatory requirements
• Support investigations of quality issues, including documentation of nonconformances
• Assist in root cause analysis and implementation of corrective and preventive actions (CAPA)
• Collaborate cross-functionally with Manufacturing, Quality, and Engineering teams to resolve quality concerns
• Contribute to continuous improvement initiatives to enhance product quality and operational efficiency
• Support compliance with FDA QMSR/21 CFR Part 820 and ISO 13485 standards

• Associate degree required; bachelor’s degree preferred in Life Sciences, Engineering, Quality, or a related field
• Minimum of 2 years of experience in a regulated environment (pharmaceutical or medical device industry preferred)
• Working knowledge of Quality Management Systems and document control processes
• Familiarity with FDA QMSR/21 CFR Part 820 and/or ISO 13485 requirements
• Experience with Electronic Document Control systems (EDC), with Master Control preferred
• Strong attention to detail, organization, and analytical problem-solving skills
• Effective written and verbal communication skills
• Proficiency in Microsoft Office and quality systems

* Position is onsite in Lewisberry

NIPRO is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local laws.

We are dedicated to fostering a workplace that values diversity, equity, and inclusion, and where everyone has the opportunity to succeed.