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.

This role is responsible for ensuring the site’s GMP Document and Records Management process is followed within the document management system, including electronic documents and records. This includes supporting site functions to maintain clear, accurate, and compliant Quality Management procedures. This role ensures all documentation aligns with regulatory standards, internal quality systems, and customer requirements.This position requires solid understanding of the document control lifecycle within the medical device/IVD industry, including management of paper and electronic documents and records including, approval, versioning, distribution, archiving, obsolescence, metric tracking, and training delivery.Maintain a variety of technical documents within the Quality System including:Standard operating procedures (SOPs)Work InstructionsAssociated GMP record

Troubleshoot issues within the electronic document management system, ensuring document accuracy and alignment with processesEnsure documentation complies with applicable regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, IVDR)Provide training, support and guidance to organization as neededServe as the document control representative on projects and global teamsMaintain controlled documents in document management systems  (approval, versioning, distribution, archiving, obsolescence)Revise documents for both technical and non-technical audiences, adapting content to meet user needs and regulatory requirementsPerforms and/or supports internal and/or external audits as requiredPerforms other related duties and projects as business needs require at direction of managementPerform records management duties as neededPerform data collection and analysis to create and maintain quality metrics for review, identification, and escalation of document and records control trends and areas of improvement.

Your Expertise:

Bachelor’s degree in Life Sciences, Engineering, English, Technical Writing, or related field2+ years of experience in technical writing within a regulated industry (preferably medical devices, pharmaceuticals, or biotech)Familiarity with Medical Device and IVD regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, IVDR)Solid knowledge of regulated and GMP document control lifecycle (approval, versioning, distribution, archiving, obsolescence)Exceptional written, proofreading, organizational and verbal communication skills with acute attention to detailStrong communication and interpersonal skills, with the ability to collaborate across multiple departmentsAbility to multitask and manage multiple priorities in a fast-paced environmentProficiency with MS Office (Word, Teams, Visio, Excel, PowerPoint), AdobeExperience with Electronic Quality Management Systems a plus

This position is a 5 day a week, in-office position located at our Newark, DE, site.

Who we are: We are a team of more than 73,000 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 annual base pay for this position is:

Min $71,000 - Max $106,400

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.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

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.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

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