Quality Engineering Document Control Specialist-Newark, DE

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Join our team and help ensure the quality, accuracy, and compliance of critical documentation that supports products impacting lives. We’re seeking a detail-oriented Document Control Specialist to drive excellence in our GMP document and records management processes. What You’ll Do: Manage the full document lifecycle (approval, versioning, distribution, archiving, obsolescence) Maintain QMS documentation including SOPs, Work Instructions, and GMP records Ensure compliance with FDA (21 CFR Part 820), ISO 13485, MDR, and IVDR Support and troubleshoot the electronic document management system ( eDMS ) Collaborate cross-functionally to create and improve documentation Provide training and guidance on document control processes Support audits, CAPA activities, and continuous improvement Track and analyze quality metr...