Quality Engineer Complaints
Biocartis NV / Email: HR@biocartis.com
- Function Type
- Full time
- Experience Required
You have at least 5 years of relevant experience in an IVD – Medical Diagnostics manufacturing environment;
Profound understanding of different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, GMP, …);
Bachelor or Master degree in engineering or life sciences (biomedical, chemical, pharma…);
- Functional Area
- Travel Percentage
Purpose of the position
The Quality Engineer Complaints will coordinate the follow-up of complaints, in close collaboration with all departments involved (primarily coordinating with the Customer Service, Sales, System Engineering, Supply chain and Manufacturing Departments). The Quality Engineer will report to the QMS Manager.
The function holder will be responsible to:
- Proactively manage complaints to assure a prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to management;
- Review all registered complaints for completeness;
- Drive investigations in collaboration with other departments, related to complaints, to obtain thorough root cause analyses and adequate definition of an action plan;
- Coordinate corrective and/or preventive actions related to complaints, and follow-up of their timely implementation and effectiveness;
- Develop new and improve existing processes and procedures related to complaints;
- Organize and provide training of personnel in relation to management of complaints;
- Identify complaint trends and call for action from the organization when action is needed to improve trends that require improvement;
- Present KPI data on monthly management meetings;
- Participate in audits performed by external parties.
Profile and competencies
- Bachelor or Master degree in engineering or life sciences (biomedical, chemical, pharma…);
- You have at least 5 years of relevant experience in an IVD – Medical Diagnostics manufacturing environment;
- Profound understanding of different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, GMP, …);
- Profound experience in participating in deviation investigations, determining root cause, and developing corrective action plans;
- You are customer focused;
- You work very accurately and have an eye for detail;
- Excellent organization and prioritization skills, and able to adapt to changing priorities;
- Good analytical and conceptual thinking skills with the ability to solve key problems;
- You are an excellent communicator, verbally and in writing, with good decision making skills;
- Able to comprehend processes in short time frames;
- Able to work in team and influence others;
- Advanced knowledge, orally and in writing, of Dutch and English;
- Experienced with MS Office (i.e. Word, Excel & PowerPoint).
We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.
Please apply by e-mail (motivational letter and CV in English) to HR@biocartis.com using the job ID 2016018 as a reference.