Quality Engineering Document Control Specialist-Newark, DE

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 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 

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

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.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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