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Johnson & Johnson

NL - Senior Quality and Validation Engineer

Posted Feb 26, 2021
Job ID: JJJP00005911
Location
Groningen
Duration
9 months
(Apr 1, 2021 - Dec 31, 2021)
Hours/week
40 hrs/week
Payrate range
81 - 84 €/hr

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.


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