NL - Senior Quality and Validation Engineer

Johnson & Johnson Vision is currently recruiting a Quality and Validation Engineer for our site in Groningen.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science, bringing innovative ideas, products and services to advance the health and well-being of people.

As a Quality and Validation Engineer you will work on several projects for several ophthalmology products with the focus on new lenses.

(ISO Nr. 11979 intracular lenses, 13485)

Key Responsibilities:

•  Contributes to the manufacturing readiness activities as a team member of the NPI development projects.
• Contributes to planning and execution of engineering activities to ensure manufacturing process readiness for transfer NPI products. 
• Works closely with R&D Engineering Subject Matter Experts to effectively define strategies and execute in compliance with Design Control Procedures.
• Conducts hands-on process development and engineering using strong experiment and statistical analysis techniques. 
• Takes ownership in executing product and process development strategies.
• Authors and review protocols and technical reports under Design Control for NPIs.
• Partner with cross-functional team members to define the impact of regulatory requirements and medical device industry trends/practices.
• Process validation experience, able to propose and execute modification.
• Executing end-to-end processes.
• Preparing documents, understanding regulatory requirements, data analytics, protocols, reposts.
• Reviewing and approving documents from other engineers.
• Making proposals to improvements, CI, reducing costs/amount of documentation - strategic level and approach.
• Engagement on Senior Level, site management, consequences, Improvement Management (Continous Improvement) wider perspective and proposal, shortcuts regulatory pathways

Requirements:

•  Medical devices, Pharma, ophthalmology experience highly desirable.
• Knowledge of SAP, MiniTab, Agile
• Data Analysis experience, Statistical experience Process Development experience nice to have.
• Experience with test method validations, and process qualifications.
• Working knowledge of the process and product development.  
• 5 years experience in the medical device industry highly preferred.
• Strong communication, organizational, and interpersonal skills.
• Understanding ISO regulations (medical devices: 13485, 11979…), intraocular lenses.

EXTRA INFORMATION:

• Flexible working hours.
• You can work remotely because of COVID-19, but you are also expected to come on-site once in a while.
• This is a contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Yacht. Yacht can offer you a payroll contract for the duration of the assignment at J&J or a freelance (ZZP'er) contract.