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ジョブタイプ: Voltijds
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仕事内容
miDiagnostics is at the forefront of releasing its first product, an ultra-fast PCR test, into the market. This market introduction means rapid organization scaling and supporting the international growth ambitions of the company. For the further development of the Quality team, miDiagnostics is looking for a Complaint Engineer, who will report to Quality Systems Lead.
As our Complaint Engineer, your responsibilities will include:
- Responsible for internal complaint management: receiving & logging product complaints, coordinating root cause investigation and corrective action planning with cross functional groups; issuing complaints reports;
- Responsible for external communication with customers on the progress and resolution of complaints;
- Keep details records and ensure diligent reporting;
- Support the evaluation of timely vigilance assessments and recall, as required;
- Act as a back up for the Compliance Officer for vigilance reporting;
- Prioritize and escalate issues in a timely manner;
- Report on status and progress of complaints to leadership;
- Partner and support other colleagues in various teams, particularly Operations and Development.
- Masters degree in a scientific discipline in a life science related field: (micro)biology, (bio)chemistry, (bio)chemistry engineering technology;
- Previous experience in complaint management or technical investigations in healthcare industry;
- Experience operating in a medical device (ISO 13485), IVD or pharma setting is a plus;
- Strong communication skills;
- High attention to detail;
- Well organized and ability to work in a structured and methodological way;
- Work well in a team but equally can operate autonomously with personal accountability for objectives;
- Ethical attitude and high integrity;
- Comfortable working in a fast-paced start-up environment;
- Flexible attitude, change minded and eagerness to learn;
- Fluent in English (written and verbal);
- Comfortable with Microsoft Office – Word, Excel, etc;
- Our offices are located in Leuven (Belgium). Relocation to Belgium is needed. It is essential that you hold entitlement to work and live in Belgium.
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締切: 31-12-2025
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