Quality Engineer (m/w/d)

Auris Health

Auris Health

Quality Assurance
Posted on Saturday, September 9, 2023


Manufacturing Quality Engineer (m/f/d)

Fixed-Term (2 years) - Full Time or Part Time 80%

Location: Norderstedt (near Hamburg)

The Manufacturing Quality Engineer is managing changes throughout the Life Cycle for launched products. He / she ensure compliance with company policies and procedures and recommendation involving the implementation of regulatory requirements. He /she utilize the Quality technical tools, process, and system to support appropriate execution of the quality system. And with that he / she supports risk management activities for product changes and guide for process changes and process deviations

Under general direction and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures, and guidelines, you have following:

Duties & Responsibilities

· Utilize Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle

· Utilize quality engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision

· Ensure effective risk management to prevent unanticipated failure modes and ensure capability

· Develop, implement, and maintain the appropriate Process Control Plan in alignment with Quality Plan

· Ensure the development and validation of appropriate test methods for product and process performance, process controls and process risk management

· Ensure effective quality strategies for validation

· Lead and/ or support of CAPA´s

· Functions as a project member in matters relating to Quality Engineering

· Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, statistical process control, and development of sample plans

· Ensure effective change control

· Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action

· Support and maintain a state of inspection readiness

· U tilize the safety and environmental regulations of the facility

· Is responsible for communicating business related issues or opportunities to next management level

· The position will interact with outside organizations such as health authorities (e.g. FDA,

· ANVISA, etc.) and notified bodies (e.g. BSI)

· Is responsible for ensuring personal and company compliance with all Federal, State, local and Company regulations, policies, and procedures

· Performs other duties assigned as needed



· At a minimum, a bachelor’s degree or equivalent in Engineering, Life Science, Pharmacy or Physical Science

· Two years’ experience in a regulated healthcare industry (pharmaceuticals, medical device, biologics, or equivalent) is desirable

· Professional / Technical Experience in:

o Manufacturing environment desirable

o Statistical Skills (Green Belt or comparable) desirable

o Basic knowledge in Quality and Regulatory framework

o Problem Solving skills

o German, fluent

o English, fluent

We are offering you a diversified position with a variety of responsibilities in a dynamic and complex international environment. If you we have sparked your interest then please send us your complete online application (CV, cover letter) in English.

What we offer

Our employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We do everything we can to enable you to develop your full potential with us.

We are very proud of our open, appreciative corporate culture and value a healthy balance between work, family and leisure. Flexible working time models such as part-time, flexible time and home office can be adapted to your life. Our proactive health program and our company fitness center take care of your mental and physical well-being.

Working at Johnson & Johnson

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Germany are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Severely disabled applicants will be given special consideration if they are equally qualified.