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 metrics
What You Bring
Bachelor's degree in related field.
2+ years of document control or quality systems experience in a regulated industry. Manufacturing experience preferred.
Strong understanding of GMP documentation processes
Excellent writing, proofreading, and organizational skills
Ability to manage multiple priorities and collaborate cross-functionally
Proficiency in MS Office and Adobe; eQMS /SAP experience is a plus
Why Join Us
Make an impact in a quality-driven environment
Work with cross-functional and global teams
Support product quality and patient safety
To find out more about Siemens Healthineers businesses, please visit our company page here .
The base pay range for this position is:
$81,780 - $112,453
Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.
EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here .
Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.
Benefits
Health insuranceDental insuranceVision insurance401(k)
Additional Information
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.
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