Johnson & Johnson Careers
Quality System Engineer
Requisition ID: 1805674205W
&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 manufacture of these products.
Do you have an affinity with quality systems that enable you to put the rest of the organization in its full power and do you want to work on the cutting edge of quality and production? Our Quality Assurance department is to strengthen the team looking for a
As a Quality System Engineer you are aware of the applicable regulations concerning the development and production of medical devices and you know the internal procedures. You have a pragmatic and critical attitude that ensures that the site is in compliance and delivers products of high quality.
For various processes including Non-conformance/Capa, Good Documentation Practice, Risk management, Validation, Management review, Regulatory standard implementation, responsible for:
- Developing and revising procedures
- Monitoring of the process execution
- KPI (Key Performance Indicator) reporting
- Employee taining
- Continuous improvement.
- Keeping the Site Quality Manual up-to-date;
- General support in the quality department, including reviewing of documentation on a variety of subjects;
- (Co-) host external (e.g. DEKRA / FDA) and
- Some years of relevant work experience as quality system specialist, preferably in the pharmaceutical or medical device industry;
- At least a relevant bachelor degree (technical, life science or related);
- Knowledge of non-conformance / CAPA management. Knowledge of EtQ is a plus.
- Knowledge of Risk Management (Failure Mode and Effect Analysis)
- Knowledge of validation of products, equipment and processes;
- Knowledge of relevant regulations (GMP, MDD, QSR CFR 820, ISO (3485, 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
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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.
that contributes to the quality of life as a global partner in healthcare.
Johnson & Johnson is at the forefront of a new era in total healthcare
AMO Groningen BV (8358)