Manager Quality Testing

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job 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 .

As guided by Our Credo Johnson & Johnson is responsible to ou

r employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 Cardiovascular

Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats 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 3000 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.

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.

duties & responsibilities

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• 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

Required Skills:

Preferred Skills:

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 locations 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.