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Κατηγορία

Περιοχή

Απασχόληση

Εταιρία: RANDSTAD
Ημερομηνία δημοσίευσης: 20-06-17
Τύπος απασχόλησης: Πλήρης
Κωδικός θέσης εργασίας:
Κατηγορία: Μηχανικοί
Περιοχή: Βόρειος Τομέας Αθηνών

Quality Assurance Engineer

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.

Responsibilities

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) 

Requirements

  • 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

Information

Vasiliki Mavrokefalou
+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.

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