Quality Control Engineer
As our Quality Control Engineer, you will take the lead in creating Quality Control inspection requirements for incoming goods, in process controls and outgoing inspections.
You will take responsibility for ensuring that QC instructions are created and maintained in order to maintain the quality standards of the products of miDiagnostics.
- Work with technical documentation from suppliers and partners to create the Quality Control instructions for incoming inspections.
- Interface with engineers from Development and Operations teams to ensure that accurate and adequate QC instructions and testing methodologies are created, reviewed and approved in line with project deliverables.
- Partner with specifications, purchasing and logistics teams to ensure specification requirements are clearly communicated to suppliers and partners.
- Take ownership of non-conformances processes to ensure appropriate technical and regulatory review is carried out prior to disposition of no-conforming product.
- Communicate with team members regarding QC requirements. You will also work with internal teams to create Critical to quality (CTQ) elements and links these to QC instructions.
- Do the interpretation of standards and regulations, as appliable to product and component QC testing and inspection.
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 control in a medical device, IVD or pharma setting.
- Prior Quality experience in the IVD industry or the medical device industry. Knowledge of Quality System standards/regulations (ISO 13485, 21 CFR 820).
- Experience of defining requirement, particularly test requirements.
- Expert in chemistry, analytical testing.
- 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, lab test protocols
- 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.
- You understand the principles of process and test method validation, eg Gauge R&R, precision, accuracy
- You are highly literate and numerate.
- You are familiar with a variety of the statistical concepts and practices, including test method validation and sampling techniques.
- You rely on extensive experience and judgment to plan and accomplish goals.
- 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