Quality Engineer

Quality Engineer 

Location: Schaffhausen, Switzerland

Hours: 40h

Hybrid way of working, on-site 3 days per week 

Imagine your next role as a Quality Engineer supporting QA Engineering for qualification projects and systems. Ensure QA oversight, Data Integrity, and Computer System Validation for Laboratory computer systems. Assure compliance of Cilag projects in Pharma/Chemical/NPI across various areas with internal and external requirements/regulations.

Key responsibilities: 

• Compliance with the GMP, EHS, and SOX requirements and guidelines, which are connected to the respective function.  

• Assure review for compliance and approval of all critical equipment qualification deliverables, and documents in Laboratory areas mentioned above.  

• Continuously proactively observe, communicate, and implement possible areas for improvement.  

• Attend trainings relevant to the successful execution of the function.  

• Keep up-to-date with current regulations, industrial standards, and new developments in the field of Quality Assurance for support with authoring Standard Operating Procedures, Work Instructions, etc for the above-mentioned.  

• Provide input for evaluation of changes (change impact/risk assessments) for Schaffhausen site manufacturing business units as mentioned above.

• Support global and local projects about Computerized System Validation with a focus on Data Integrity for areas such as Periodic Reviews for Laboratory systems and Transfer Projects of spreadsheet documentation.  

• Support Commissioning / Decommissioning of software applications and operating systems.  Advise Cilag Project Managers on qualification aspects with the aim of integrated project documentation being regulation-compliant.  

• Manage the role of departmental Training Curriculum Coordinator

how to succeed:

• A bachelor's degree or higher in engineering, quality assurance, or a related field. 

• Previous experience in quality engineering, particularly in a laboratory or equipment testing environment. 

• Understanding equipment validation processes and regulatory compliance in laboratory settings is essential.

• Strong analytical skills and ability to identify areas for improvement in equipment performance and reliability.

• Knowledge of laboratory equipment and instrumentation, and familiarity with testing procedures, protocols, and documentation practices.

• Experience in regulatory compliance and GMP

• Excellent communication skills, both verbal and written, in English and a good level of German language as well. 

• Attention to detail, teamwork, and continuous improvement mindset 

benefits

This role offers a competitive hourly rate & a supportive working environment. The role will run initially for a year and the first contract is initially until 31/12/2024. 

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

https://www.jnj.ch/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact:  katerina.alikaridou@randstadsourceright.nl

Diversity, Equity & Inclusion

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 are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each 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”.