Manager Quality Testing

Job Overview

Manager Testing, Heart Recovery – Aachen

Location: Aachen, North Rhine-Westphalia, Germany

Job Category: People Leader (Quality). The role focuses on managing and organizing all testing activities at the Aachen site.

Johnson & Johnson is committed to an inclusive work environment where each person is considered as an individual. We respect the diversity and dignity of our employees and recognize their merit.

Responsibilities

• Organize, lead and represent the AAC testing department
• Design and execute tests to verify product meets requirements & specifications
• Support system reliability testing (SRT) and SPC program to evaluate system-level design quality
• Support 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
• Collaborate in cross‑functional teams that span global operations
• Proficient in English and German verbal and written communication; may require traveling between facilities
• Use Lean and Six Sigma tools to analyze trend data (e.g., SPC charts) and perform data analysis to support test conclusions
• Support the continuous‑improvement process
• Support feasibility, DV, V&V, EFS, process validation and product changes/enhancements in coordination with Operations, Product Development and Quality Control
• Support and enforce company goals, objectives, policies and procedures, Good Lab Practices, Good Documentation Practices, FDA QSR, and ISO regulations
• Develop, optimize, and qualify test documentation: test procedures, methods, fixture specs, IQ/OQ/PQ, Gage R&R studies, Process Capability Studies, DOEs
• Identify and execute test method validations including generation of plans, protocols and reports
• Plan and schedule projects, estimating required timing, resources and budgets consistent with corporate objectives
• Participate in the investigation and implementation of internal corrective actions, audit findings, and QN assignments in a timely manner
• Maintain accurate documentation of concepts, designs, and processes while staying current on medical, technical, and biomedical developments
• Communicate business‑related issues or opportunities to the next management level
• Ensure compliance with health, safety and environmental practices at all times
• For supervisory roles, ensure staff follow company guidelines and have necessary resources
• Ensure personal and company compliance with all federal, state, local and company regulations, policies, and procedures
• Perform additional duties as assigned

Experience & Education

• 5+ years of medical device experience (preferred)
• Engineering university degree

Required Skills

• Compliance Management
• Corrective and Preventive Action (CAPA)
• Cross‑Functional Collaboration
• Developing Others
• Fact‑Based Decision Making
• Good Manufacturing Practices (GMP)
• Inclusive Leadership
• ISO9001
• Leadership
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Risk Assessments
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Team Management

Preferred Skills

• Advanced knowledge of German & English (speaking and writing)
• Experience working in a regulatory‑controlled environment
• Technical understanding of medical device testing and regulatory requirements
• Proficiency in Lean and Six Sigma methodology
• Experience with CAPA implementation
• Strong data analysis and SPC skills

Salary & Benefits

The anticipated base pay range for this position is €78,300 – €135,700 per year.

Benefits include:

• Annual bonus with a target based on company and employee performance
• Vacation days and paid parental leave (minimum 12 weeks)
• Bereavement leave, caregiver leave, and volunteer leave
• Well‑being reimbursement programs
• Program for financial, physical, and mental health support
• Service anniversary and recognition awards
• Participation in various insurance plans (dependent eligibility varies by location)