Quality Assurance Engineer
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) and Shunts. The site is worldwide responsible for the design and for the manufacturing of these products.
Do you want to contribute on the edge of quality, driving product and new technology development from a Quality perspective? Or do you excel in supporting day-to-day operations? Do you have affinity with medical devices, like to work in an agile and ambitious environment with a global outreach? Our Quality Assurance department is looking for quality professionals to strengthen our team.
Quality Assurance Engineer
We are looking for highly skilled and experienced Quality professionals, to either support product/technology development or support the manufacturing.
As a Quality Assurance Engineer you have a good working knowledge of the applicable regulations regarding the development and production of medical devices, in line with the Medical Device Directive 93/42/EEC, 21CFR Part 820 and ISO 13485 and ISO 14971.
You have a close loop approach to quality, like working in multifunctional 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.
Depending on the focus area that you will work in, the following tasks will be included:
- Act as key quality representative in multidisciplinary team to support new product/technology development projects
- Or act as quality representative in Operational Groups, ensuring product/production meets standards and specifications
- Ensure that all performance, quality and compliance reviews are done in a timely and compliant manner and followed up as needed
- Review and approve project and quality documentation, ensuring that the change control procedures are applied correctly
- Ensure qualifications and validations of products/equipment/ processes are meeting standards
- Perform or support non-conformance / CAPA root cause investigations, and drives these to completion.
- Identify critical areas for continuous improvement and prioritize and execute the quality improvements initiatives resulting from this.
- Escalate any quality or compliance issues to upper management
- Process owner of risk management and setting up risk management documentation (FMEA) with a multidisciplinary team.
- Support, perform and assess statistical analyzes and support in the implementation of statistical process control techniques, sampling schemes and other quality techniques
- Communicate recent developments about Standards and cGMP in your area of work and ensure that these are implemented
- Responsible for inspection readiness of the projects or tasks in scope of your work, and act as an Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA);
- Work closely together and maintain a relevant network of contacts with quality and other expertise within J&J Surgical Vision 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:
- Minimum of five years of relevant work experience preferably in the pharmaceutical or medical device industry;
- Bachelor or Master of Science degree (technical, life science or related);
- Working knowledge of Quality system management, Risk Management, Change Control, Validation of products/equipment/ processes, Statistics;
- Knowledge of relevant Medical Device regulations (GMP, MDD, 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.