Are you an Engineer with strong interpersonal, communication and coordination skills?
Can you effectively manage product problem reports and coordinate cross-functional teams and activities?
Are you willing to be part of a challenging environment with plenty of opportunities ahead? If yes then this is a great opportunity within a leading company in the healthcare industry.
Customer complaints management
- Manage the end to end process of customer complaints including review and maintenance of complaint files and responses sent to customer
- Communicate with customers to gather information regarding the reported technical problems
- Coordinate and prioritize the technical investigations and corrective actions performed by the engineering team
- Participate in technical investigations of the complaints, the risk assessment and implementation of corrective and preventive actions
- Organize customer complaint review board meetings
- Initiate and coordinate the materiovigilance activities according to applicable regulations
- Communicate within the organization and customers the containment, corrective and preventive actions
- Prepare final reports - answers to customer complaints
- Generate, validate and present various Quality metrics pertaining to complaints
Change control management
- Lead execution of process and product changes from the Request to the Closure
- Exact formulation and documentation of a change request
- Insertion/Registration of a documented change request into the internal Change Management tool
- Documenting the Impact Assessment of the change on the related documentation (according to internal procedures)
- Organizing CCB (Change Control Board) meetings:
- for the first evaluation, bucketing and prioritization of changes
- for the following-up of the implementation stages
- Coaching/Mentoring of the designated staff - throughout all the affected departments
- Ensuring the traceability of a change request throughout the whole process and product documentation (Documented References / internal change management tool)
- Supervising and updating:
- the revised DHF, DMR and STED Files of the products (Design Output), with the help of the experts, in paper and electronically
- the revised Procedures, Guidelines and Forms of the Quality Management Manual, with the help of the experts, in paper and electronically
- Closing the change requests formally (against the Impact Assessment / internal change management tool)
- Monthly Reporting of the Status of all Changes (regular and CAPA projects)
- Electrical Engineering or other engineering degree
- 5 years of engineering (R&D) or quality (QA) experience, preferably in regulated industry (e.g. medical device, pharmaceuticals)
- Knowledge of ISO9001, ISO13485 or other quality management system
- Excellent inter-personal, written and spoken communications and abilities
- Excellent speaking and writing in English
- Written and oral communication skills in French is plus
- Strong project management skills
- Ability to work alone and with a team
- Having problem solving attitude
+30 210 6770523
Please note that after the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. All applications are considered strictly confidential.
Follow us on • Linkedin • Facebook • Twitter.
For articles and career tips visit our blog.
Click here to apply now