As our Specifications Writer, you take the lead in creating component, material, process and product specifications.
You will work with technical documentation from suppliers and partners to create Medical Device specifications.
You take responsibility for ensuring that accurate and adequate specifications are created and maintained.
- Interface with engineers from Development and Operations teams to ensure that accurate and adequate specifications are created, reviewed and approved in line with project deliverables.
- Partner with purchasing and logistics teams to ensure specification requirements are clearly communicated to suppliers and partners.
- Take ownership of design change processes to ensure appropriate technical and regulatory review is carried out prior to implementation.
- Communicate with team members regarding specification requirements. You will also create Critical to quality (CTQ) elements and links these to QC instructions in collaboration with QC and Operations teams members.
- Do the interpretation of standards and regulations, as applicable to product and component specifications.
You are a key member of the Quality Team and you will be reporting to our VP Quality & Regulatory Affairs.
- Master's degree in a scientific discipline and at least 4 years of experience in quality or in a closely related area with technical writing requirements.
- Prior Quality experience in the IVD industry or the medical device industry. Knowledge of Quality System standards/regulations (ISO 13485, 21 CFR 820).
- Highly literate and numerate.
- Familiar with a variety of the statistical concepts and practices
- You rely on extensive experience and judgment to plan and accomplish goals.
- Experience of writing specifications.
- Expert in Microsoft Word, Excel, Powerpoint, databases, etc
- You work well in a team but you equally can operate autonomously with personal accountability for objectives.
- Ability to analyze and interpret technical procedures and governmental regulations.
- Ability to create technical reports, business correspondence, technical procedures, as well as, administrative procedures.
- Ethical attitude and high integrity.
- Ability to present proposals, data, and issues to miDiagnostics personnel at all levels.
- Ability to represent the team in frequent cross-functional interactions with regulators, subcontractors, and/or vendors.
- You are fluent in English. Knowledge of Dutch is an asset
- Our offices are located in Leuven (Belgium). Relocation to Belgium is needed
- You’re entitled to live and work in Belgium
- You feel comfortable in a start-up environment and you can easily switch from one task to another
- You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues