Commercial Quality Mdr Inspector
il y a 3 semaines
Johnson & Johnson is recruiting for an I **nspector MDR Verification **. This position can be located in Courcelles (Belgium) or Selzach (Switzerland). Remote locations within the EU may be considered.
The Inspector MDR Verification is responsible for conducting detailed verification processes for distributors and importers (Economic Operators) of Medical Device Regulation (MDR) products being supplied to the EU market. The main goal is to ensure compliance with regulatory requirements and promote the safety and quality of medical devices.
**Key Responsibilities**:
- Conduct verification checks of distributors and importers of MDR products supplying the EU market on site (Courcelles, La Louvière, Selzach) and/ or remote
- Collaborate with cross-functional teams within Deliver, Commercial Quality and all MedTech Franchises to gather vital data and documentation for the verification
- Analyze information collected during the verification process to identify any non-compliance issues or potential risks
- Work in various systems, e.g. such as PLM, Labeling and ERP systems, to verify compliance of MedTech products
- Document Non-conformities, follow up actions and drive improvements
- Prepare comprehensive reports detailing the findings of the verification process and recommend appropriate actions to ensure compliance
- Connect with distributors, importers, and other relevant partners to address any concerns or queries
- Provide mentorship and support to internal teams regarding standard methodologies for selecting and collaborate with other Economic Operators in the Johnson & Johnson organization
- Collaborate with regulatory partners and participate in audits or inspections related to, if required
- Support continuous process improvement projects related to EO verification
- Support IT validation and testing (UAT) related to EOV system, if required
- Support documentation improvements, implementation and trainings
**Qualifications**:
**Education**:
- A Bachelor’s degree or equivalent experience in Computer Science, Information Systems, Business Administration, or another related field required
**Experience and Skills**:
**Required**:
- Proven experience as an Analyst, preferably in the area of Commercial Quality, Regulatory Affairs, Supply Chain
- Experience in conducting compliance verification or audits
- Familiarity with Quality Management Systems (QMS) and Risk Management process
- Excellent analytical and problem solving skills are a super important.
- Strong verbal and written communication skills with the ability to communicate effectively with personnel of all levels with the organization
- Strong analytical skills combined with a high level of creativity, highly diligent with strong interpersonal and follow-up skills
- Proficient in using relevant software and tools for data analysis and documentation
**Preferred**:
- Solid understanding of Medical Device Regulation (MDR) requirements and relevant EU regulations
**Other**:
- Proficiency in English, German and French is a plus
- Travel may be required for meetings or training purposes
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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