QA Engineer Complaint Handling

Job description

Job Description

Requisition ID: 1805641587W

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.

Do you want contribute on the edge of quality, production in a lean process production environment? Do you have affinity with R&D and Technology? Our Quality Assurance department is currently looking out for two new quality professionals.

(Junior) Quality Assurance Engineers – We also invite ambitious starters with a technical background to respond to this vacancy.

As a (Junior) Quality Assurance Engineer you are aware of the applicable regulations regarding 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.

In this role you contribute directly to product and process development projects. You can think of projects to develop a new Intraocular Lens, or to further develop technology to produce the lenses. Within development projects you are the owner of risk management and you set up risk management documentation (FMEA) with a multidisciplinary team. You ensure that the change control procedures are correctly applied and you review project documentation. Preferably you have knowledge of process and product validation.

Main tasks
·  General support in the quality department, including reviewing documentation, providing advice on drafting protocols or procedures on a variety of subjects;
·  Perform and assess statistical analyzes and support in the implementation of statistical process control techniques, sampling schemes and other quality techniques;
·  (Co-) host external (e.g. DEKRA / FDA) and internal audits;
·  Performing non-conformance / CAPA root cause investigations and defining action plans.

Desired profile

Qualifications

Qualifications

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:

·  Some 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

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

Primary Location
Netherlands-Groningen-Groningen
Organization
AMO Groningen BV (8358)
Job Function
Quality (Eng)
Requisition ID
1805641587W