Job Summary

The Document Control Site Leader (m/f/d) serves as a subject matter expert (SME) for document control, change management, and master data governance within Abiomed’s Quality Management System (QMS) for our Aachen, Germany facility. This role provides leadership in the execution and continuous improvement of document control processes, supports Change Control Board (CCB) activities, and ensures the integrity of SAP master data related to quality and manufacturing documentation. The position partners cross-functionally with Quality, Regulatory, Manufacturing, R&D, Supply Chain, and other global stakeholders.

Key Responsibilities – Document Control & QMS Leadership:

- Lead and oversee the full lifecycle management of controlled documents within the electronic document management system (SAP).
- Ensure global compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and MDSAP requirements.
- Serve as an escalation point and mentor for junior document control personnel.
- Perform advanced quality reviews for document accuracy, formatting and regulatory alignment.

- Provide expert support during internal, customer, FDA and Notified Body audits by ensuring controlled documentation, change records and SAP master data are accurate, complete and inspection ready.

- Acts as key audit support lead for change control and quality documentation; coordinating the retrieval, review and presentation of controlled documents, change controls and SAP master data during internal and external audits, ensuring compliance with regulations.

- Oversee the end-to-end document control process. Serve as a subject matter expert (SME) for Document Control processes during internal audits, FDA inspections, and Notified Body assessments.

- Analyze trends and metrics to identify systemic issues and recommend strategic quality improvements.

- Collaborate with cross-functional teams including Manufacturing, R&D, Regulatory Affairs, and Quality Operations to resolve quality issues and implement sustainable solutions.

Key Responsibilities – Change Control Board (CCB):

- Actively support and serve as facilitator of the Change Control Board review meetings.
- Coordinate administrative review of change control activities including impact assessments, documentation updates, and approvals.
- Ensure change records are complete, compliant, and audit-ready.
- Monitor CCB metrics and drive timely closure of functional impact assessments, administrative review and change control board approvals.

Key Responsibilities – SAP Master Data Management:

- Maintain and govern SAP master data related to documents, materials, BOMs, routings, and quality records.
- Ensure alignment between SAP master data and QMS documentation.
- Support SAP change requests, validations, and data integrity initiatives.
- Partner cross-functionally to resolve master data discrepancies.

Audit, Training & Continuous Improvement:

- Support FDA, Notified Body, and internal audits
- Develop and deliver training on document control, change management, and SAP procedures.
- Lead or support Kaizen and continuous improvement initiatives.

Required Qualifications:

- Bachelor’s degree or equivalent experience.
- 5+ years of experience in document control or quality systems in a regulated industry.
- Experience with Change Control Board or Change Review Board activities.
- Hands-on master data experience.
- Strong knowledge of ISO 13485, FDA QSR, and EU MDR.
- Experience with eDMS platforms.

- Proficient in both verbal and written English communication.

Preferred Qualifications:

- Medical device industry experience.
- SAP S/4HANA experience.
- Audit and inspection experience.
- English fluency required; German preferred.

Key Competencies:

- Subject Matter expertise in document and change control
- Strong attention to detail and systems thinking
- Ability to influence in a matrixed organization
- High integrity and accountability

Other

• Up to 10% travel may be required to support:

• Regulatory inspections and internal audits at other facilities

The anticipated base pay range for this position is 75.000 EUR to 118.450 EUR.

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Required Skills:

Preferred Skills: