Johnson & Johnson Careers
Validation Quality Engineer
Requisition ID: 1905730608W
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 manufacture of these products. A project has started to further develop IOL manufacturing technology with a high degree of automation. Therefore, the Quality Department is looking for a
Quality Assurance Engineer – Design Quality and/or Process Validation oriented
As a QA Engineer you have a good working knowledge of the applicable regulations regarding the development and production of medical devices, in line with the Medical Devices Regulation, 21CFR Part 820 and ISO 13485 and ISO 14971.
Within our quality department there are several areas of focus. In this role your main area of focus is product, process and technology development. This includes design control, risk management, equipment and process qualification and validation.
You have a close loop approach to quality, like working in teams and projects, are result driven, while having a pragmatic and critical attitude that ensures that the site is in compliance and delivers products of high quality.
- Key Quality representative in multidisciplinary team to support new product or process development projects, ensuring compliance. Within development projects you are the process owner of risk management and you set up risk management documentation (FMEA) with a multidisciplinary team.
- Ensure correct validation processes application (IQ/OQ/PQ/PPQ) via proactive support, and review and approval of documentation.
- Support, perform and assess statistical analyzes and support in the implementation of statistical process control techniques, sampling schemes and other quality techniques
- Ensure that the change control procedures are correctly applied, and you review and approve project and Quality documentation
- Communicate recent developments about Standards and cGMP in your area of work.
- Identify critical areas for improvement 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.
- 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);
- Escalate any quality or compliance issues to upper management.
- Maintain a relevant network of contacts with quality and other expertise within JJSV and other J&J companies, but also with other MDD companies and professional associations, which will allow you to identify best practices for the work.
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;
- A relevant Bachelor or Master of Science degree (technical, life science or related);
- Working knowledge of validation of products/equipment/ processes, computer system validation, statistics, risk management, change control;
- Knowledge of relevant Medical Device regulations (GMP, MDR, QSR CFR 820, ISO 13485, ISO 14971);
- Self-starter, result driven, able to function independently as well as in a team;
- Able to work towards sound solutions in complex or seemingly conflicting situations; Flexibility and accuracy;
- Good communicative skills, excellent command of the English language and preferably the Dutch language;
- Knowledge of MS Office;
Please send your application including a motivation letter before April 28, 2019.
Are you almost about to apply but just need a small push before sending your resume? Please call Anna de Boer-Bilstra (Manager QA Engineering), +31 (0)6 2241 2116 for more information. Do you like to know more about the application process, please call Frank Helmus (Talent Acquisition Partner) +31 (0)6 11 85 21 86.
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.
A group 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 solutions.
AMO Groningen BV (8358)