Formulates the overallproject plan (including timing, budget and necessary staffing plans) inconsultation with management and other parties.Is responsible for implementation and realization according to theproject plan (specification, quality, time, money, information, andorganization). Manages project progress and takes necessary corrective actions.Directs employees within the project and gives them operationalguidance, both technically and organizationally.Manages external development partners and/or subcontractors whereapplicable. Executes projects under his/her responsibility pragmatically and inline with company processes and applicable regulations for medical devices inour target markets.Provides management board with regular project performance status,including identified risks and mitigation scenarios of the project with regardto specifications, costs, planning, etc.Reports on employees' performance toline managers and other resource owners for the purpose of performanceappraisal and makes proposals for further competence development.Minimum requirements/qualifications: These are the onlyminimum qualifications for this position at this grade level. Other factors are taken intoconsiderationwhen deciding what position and grade level to place an employee, such asperformancelevel, capable contributionlevel, and company need.
2. Education: Bachelor's Degree in engineering,science or technical field or equivalent, Master's Degree preferred.
3. Experience Seven years of working experience in a highly regulated industry.Experience with Design Control, Quality Management Systems,internal/external audits, CAPA, Change Control, Complaint handling, Transferfrom R&D to Production, Post Market Surveillance, supplier quality.Experience in resource planning and management. Knowledge of projectmanagement methods and estimation techniques.Experience with outsourcing and negotiation with 3rd parties.o4. Skills Excellent communication skills, both orally and in writingAn energetic and driven professional with organizational talent andready to take responsibility.Flexible, proactive, and a team player.Able to create a great working atmosphere.Quality-conscious, results-oriented, and business-minded.Works well in a fast-paced environmentProcess & Results oriented5. Nice to Have Working knowledge of process improvement skills, including Six Sigma,Lean Sigma, Knowledge Management, and Process Design.Experience in utilization methods such as design of experiments, riskmanagement, validation, verification, systematic problem solving, andstatistical analysis.Experience with root cause investigation methodologies
#J-18808-Ljbffr
