Quality Assurance Engineer

Quality Assurance Engineer

Location: Groningen, Netherlands - Site based

Duration: 3 months

Hours: 40 hours per week

Provide Quality Assurance support for mechanical and optical laboratory validation projects, to ensure all testing and validation activities comply with industry standards and regulatory requirements (e.g., ISO 13485).

The current need is for the following project:

• Test method validation of a Smartscope measuring device that utilizes a combination of a camera, lighting, and software for image analysis.

• The Smartscope measures dimensions and geometry of components used for manufacturing of Intraocular Lenses. 

roles and responsibilities

• Ensure quality assurance within laboratory validation projects.

• Specifies and improves test method validations

• Drafting and reviewing test method validation plans, protocols and reports.

• Ensure that testing is performed consistently and accurately according to established protocols.

• Analyze test results and measurements, utilizing statistical tools to validate outcomes.

• Manage project timelines, ensuring that testing and validation efforts align with product development schedules.

• Advising, reviewing and approving changes in test methods / work instructions, in line with the applicable procedures. 

• Evaluates compliance with applicable laboratory standards and procedures

• Validation Subject Matter Expert (SME) during projects

• Provide training to team members regarding testing procedures, work instructions and best practices.

how to succeed

• Bachelor’s degree in: Mechanical Engineering, Mechatronics, Physics, Engineering Science or Bioengineering

• 2-4 years of relevant work experience, preferably in the pharmaceutical or medical-device industry.

• Knowledge of GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971

• Knowledge of quality assurance systems (QMS)

• Knowledge of relevant work rules and procedures

• Knowledge of MS Office

• Knowledge of Minitab

• Knowledge of validation of technical systems and processes

• Knowledge of statistics and quality improvement techniques

• Communicative

• Flexible and accurate

• Able to function both independently and in a team

• Excellent command of Dutch and English language

Preferred knowledge/skills:

• Knowledge of Metrology: Understanding of measurement principles, measuring instruments, and measurement accuracy is essential for developing test methods.

• Experience with Smartscope or similar Instruments: Practical experience with optical measuring instruments and the ability to use them effectively.

• Analytical Skills: Ability to analyze and interpret data to perform accurate measurements and validations.

• Software Analysis Skills: Familiarity with software programs used for data analysis and image processing, as well as statistical analysis tools.

benefits

This role offers a very competitive hourly rate. This contract will run for 3 months

you are welcome here

Johnson & Johnson is 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.

about Johnson & Johnson Vision

Johnson & Johnson Vision brings together cutting-edge insights, science, technology and people. We partner with eye care professionals and help more people around the world preserve and restore sight. Our portfolio includes the best selling contact lens brand in the world, ACUVUE®, plus consumer eye health solutions, dry eye treatments, refractive (Lasik) and cataract products. Contribute to the next healthcare breakthrough, create a world connected by SIGHT™ with your next project at Johnson & Johnson Vision. 

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. The pay rate for this role will depend on how you are paid. 

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”.