Role DescriptionAs a Senior 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 contribute directly to product development projects. These are either projects to develop a new Intraocular Lens, or to further develop technology to mass-produce the Intraocular Lenses. 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.
Responsibilities- You are the key Quality representative in multidisciplinary team to support new product development projects. - You ensure in these project that all performance, quality and compliance reviews are done in a timely and compliant manner and followed up as needed - Within development projects you are the process 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 and approve project and Quality documentation - You have working knowledge of process and product validation and ensure correct application via proactive support, and review and approval of documentation. - You support, perform and assess statistical analyzes and support in the implementation of statistical process control techniques, sampling schemes and other quality techniques - You communicate recent developments about Standards and cGMP in your area of work. - You 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. - 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. - You maintain a relevant network of contacts with quality and other expertise within the company at large, but also with other MDD companies and professional associations, which will allow you to identify best practices.
Requirements- Minimum of five years of relevant work experience preferably in the pharmaceutical or medical device industry; - Master of Science degree (technical, life science or related); - Working knowledge of 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; - Good communicative skills, excellent command of the English language and preferably the Dutch language; - Knowledge of MS Office.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Alexander Wielemaker.