Manager Quality Testing

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: People Leader

All Job Posting Locations: Aachen, North Rhine‑Westphalia, Germany

Job Description: The Manager Testing, Heart Recovery Aachen is responsible for the management and organization of all Testing activities at the Aachen site. He/She/Them is functionally and disciplinary responsible for the management of the Test employees. He/She is responsible that all tests: conducted, designed, developed, described improved, and validated.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

About Cardiovascular

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Abiomed is an innovative medical device company with an inspiring mission of "Patients First" and a unique guiding principle of "Recover Hearts." Saving Lives." With more than 3,000 employees, Abiomed is one of the fastest growing medical technology companies in the world, with headquarters in Danvers, USA, and locations in Aachen, Germany, Tokyo, Japan and Singapore. Abiomed is part of Johnson & Johnson MedTech.

Abiomed is an employer offering attractive working conditions and a rewarding corporate culture focused on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

Duties & Responsibilities

• Organize, lead and represent the AAC testing department
• Design and execute Tests to verify product meets requirements & specifications
• Support system reliability testing (SRT), SPC program to evaluate the system level design quality
• Support the development of new products by providing test services to Engineering, Manufacturing, Research, Development and Quality Departments
• Work with product development staff to ensure that products under development are tested as appropriate
• Ability to work in Cross functional teams that span global operations. Proficient in English and German verbal and written communication. This may require traveling between facilities
• Use Lean and Six Sigma Tools to analyze trend data (e.g. SPC Charts) & Perform data analysis to support test conclusions & Support the Continuous Improvement Process
• Support feasibility, DV, V&V, EFS, Process Validation, product changes and enhancements in coordination with the Operations, Product Development and Quality Control organizations
• Support and enforce Company Goals and Objectives, Policies and Procedures, Good Lab Practices, Good Documentation Practices, FDA QSR, and ISO regulations required.
• Develop, optimize, and qualify Test documentation including test procedures, test methods, fixture specs and supporting documentation, IQ/ OQ/PQ, Gage R&R Studies, Process Capability Studies and DOEs
• Identify and execute Test Method Validations including generation of plans, protocols, and reports.
• Plan and schedule projects, estimating required timing, resources, and budgets to be consistent with corporate objectives
• Participate in the investigation and implementation of all internal corrective actions, audit findings and address QN assignments in a timely manner.
• Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments related to company products
• Responsible for communicating business-related issues or opportunities to the next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Experience and Education

• 5+ Year experience medical device experience preferred
• Engineering University Degree
• German & English: advanced speaking and writing knowledge.
• Experience with working in a regulatory controlled environment, technical understanding

Preferred Skills

• Compliance Management
• Corrective and Preventive Action (CAPA)
• Cross-Functional Collaboration
• Developing Others
• Fact-Based Decision Making
• Give Feedback
• Good Manufacturing Practices (GMP)
• Inclusive Leadership
• ISO 9001
• Leadership
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Risk Assessments
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Team Management

The anticipated base pay range for this position is: €78’300.00 – €135’700.00

Benefits

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, 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.