Johnson & Johnson Careers
Quality Assurance Engineer Operations
Requisition ID: 1805704585W
QUALITY ASSURANCE ENGINEER OPERATIONS
J&J Surgical Vision in Groningen is the Center of Excellence for the development of innovative solutions for the surgical ophthalmic market, mainly intraocular lenses (IOLs). The site is responsible for the design and manufacturing of these products.
The organization is divided into 5 core teams which generally work on a project basis and according to strong quality guidelines, in an international environment.
As a (Senior) Quality Assurance Engineer Operations you are aware of the applicable regulations regarding the production of Medical Devices. In this role you contribute directly to the manufacturing of our Intraocular Lenses.
As a Quality Engineer focused on Operations, you work in a multidisciplinary operational group and provide quality direction for all daily operational business.
- You identify critical areas for improvement related to manufacturing and prioritize and execute the quality improvements initiatives resulting from this. As needed, you perform or support non-conformance / CAPA root cause investigations, defining action plans and drives these to completion;
- You are responsible for inspection readiness of the projects in scope of your work, and act as an Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA);
- You escalate any quality or compliance issues to upper management;
- Act as Quality point of contact and decision maker during manufacturing and Change Control activities whilst ensuring that all activities meet internal and regulatory expectations;
- Analyze manufacturing data for continuous improvement purposes and reducing or eliminating sources of variation within the production process;
- General support in the quality department, including reviewing documentation, providing advice on drafting protocols or procedures on a variety of subjects.
At Johnson & Johnson every colleague makes a vital difference. Our people take pride in improving people’s health around the world. Each day, they make life better by going for high quality and continuous innovation. While doing so, they get the chance to grow their competences and take initiatives. All of this in an international, value-driven group that cares for the wellbeing of its people.
We have an experienced team, a challenging work environment and are among the absolute forerunner in the IOL market. As a future colleague, we want you to match within the following criteria:
- At least 5 years of relevant work experience preferably in the pharmaceutical or medical device industry;
- At least a relevant Bachelor Degree (Technical, Life Science or related);
- Knowledge of Risk Management;
- Knowledge of validation of products, equipment and processes;
- Knowledge of statistics;
- Knowledge of relevant regulations (GMP, MDD, QSR CFR 820, ISO 13485, ISO 14971);
- Knowledge of MS Office;
- Communicative skills, flexibility and accuracy;
- Being able to function independently as well as in a team;
- Excellent command of the Dutch and English language
AMO Groningen BV (8358)
Cilag GmbH International (8525)