Function
Quality
Sub function
Quality Systems
Category
Experienced Analyst, Quality Systems (P5)
Location
Aachen / Germany
Date posted
Jun 10 2025
Requisition number
R-011655
Work pattern
Hybrid Work
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

JOB DESCRIPTION:

Responsible for the successful implementation of record & information management (RIM) policies, procedures, and strategies at the Abiomed Aachen site in compliance with Johnson & Johnson Worldwide RIM standard as well as regulatory and legal requirements. The Abiomed Records and Information Senior Analyst, under the direction of the Records Management Manager, oversees the deployment of recordkeeping standards and controls through a federated governance model of records custodians across the business. Success is determined through the cultivation of a custodial network of practice across all Abiomed business functions which create, store, or transmit records as defined in the Enterprise Retention Schedule and other governing standards. This role acts as the records and information governance subject matter expert for Abiomed Aachen.
Duties & Responsibilities:

In accordance with all applicable federal, state, and local laws/regulations and corporate Johnson & Johnson, procedures and guidelines, this position will provide RIM oversight at the Aachen and other Abiomed sites.

• Maintain accountability for program activities at Aachen, Germany site, supporting Abiomed and Johnson & Johnson through documentation and escalation of issues or opportunities to the Records Manager.
• Deliver subject matter expertise to employees to support quality results and timely completion such as scanning initiatives or the True Copy process
• Document Aachen RIM controls and Standard Operating Procedures for availability and transparency of
• WWRIM policy.
• Ensure compliance with records which hold historical, legal/evidentiary, regulatory, fiscal, or operational value
• Establish and maintain a Record Inventory List with each Department Records Coordinator (DRC), developing and delivering work instructions and training regarding office of record and system of record responsibilities
• Demonstrate a measurable and repeatable disposition review with each DRC for the proper retention and disposition of content pursuant to the Enterprise Retention Schedule
• Assist in the accession and disposition of data for acquisition, divestiture, and facility closure activity
• Maintain the integrity of Abiomed’s information through the deployment of controlled vocabulary and metadata regarding databases, systems, websites, file shares, et cetera
• Support audit activity both internally and externally to Abiomed
• Assist Records Manager and DRC in protecting Abiomed’s business through correction of noncompliance issues.
• Audit internal offsite/vendor security controls such as storage, transportation, and scanning services
• Assist legal operations in actual/potential litigation or eDiscovery requests.
• Maintain roster of standard custodians for systems of record in cooperation with litigation activities
• Deploy data classification of records, both privileged and vital, for business continuity
• Document processes/activities and develop metrics on Aachen RIM activities to ensure transparency of
• RIM compliance

Experience & Education:

• Bachelor’s degree in archives, library, or information management, education, business, or technology required.
• 2-4 years of records management experience in a highly regulated environment such as Quality, Manufacturing, or GMP.

Knowledge, Skills, Abilities and Certificates:

• Medical device experience preferred.
• Familiarity with the Generally Accepted Recordkeeping Principles, ISO standards
• Above average fluency in German and English, both written and verbal; be able to carry a conversation
• Influence and leadership experience in accomplishing department objectives.
• Intermediate Microsoft Office 365 (SharePoint, OneDrive, Excel, Word, Outlook, PowerPoint) familiarity expected.
• Project Management skills and principled approach.
• Proven technical and analytical acumen and curiosity, along with diligence and sound judgement.
• Effective collaborator with internal stakeholders and external vendors.
• Manager of complex and concurrent projects with ability to prioritize organizational risk is preferred.
• Strong history of development, coordination, and leadership in cross-functional initiatives
• Relationship builder and willingness to put patient safety and success first.
• Work well alone and in collaborative environments.
• Current or pursuing Certified Records Analyst, Certified Records Manager or Information Governance Professional designation strongly preferred.
• Affiliation with EURBICA, AIIM, ARMA or other records management communities of practice preferred.

Please refer the Job description for details