Manufacturing Quality Engineering (m/f/d)

Stellenbeschreibung:

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

Job Function

Supply Chain Engineering

Job Sub Function

Quality Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Norderstedt, Schleswig-Holstein, Germany

Job Description

This position is a 1 year contract with potential to extend (without guarantee). The anticipated base pay range for this position is 51,200 - 92,000 Euro.

Wage level (Tarifstufe) is equivalent to E11.

The Manufacturing Quality Engineer (m/w/d) is managing changes throughout the Life Cycle for launched products. The MQE ensures compliance with company policies and procedures and recommends involving the implementation of regulatory requirements. Utilize the Quality technical tools, process, and system to support appropriate execution of the quality system. And with that the MQE supports risk management activities for product changes and guides 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 the 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 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.
Utilize 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.

Qualification

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 manufacturing and sterilization environment desirable.
Statistical Skills (Green Belt or comparable) desirable.
Basic knowledge in Quality and Regulatory framework.
Problem Solving skills.
German, fluent.
English, fluent.

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