Responsibilities:
* Formulates the overall project plan (including timing, budget, and necessary staffing plans) in consultation with management and other parties.
* Is responsible for implementation and realization according to the project plan (specification, quality, time, money, information, and organization). Manages project progress and takes necessary corrective actions.
* Directs employees within the project and gives them operational guidance, both technically and organizationally.
* Manages external development partners and/or subcontractors where applicable. Executes projects under his/her responsibility pragmatically and in line with company processes and applicable regulations for medical devices in our target markets.
* Provides management board with regular project performance status, including identified risks and mitigation scenarios of the project with regard to specifications, costs, planning, etc.
* Reports on employees’ performance to line managers and other resource owners for the purpose of performance appraisal and makes proposals for further competence development.
Minimum requirements/qualifications:
* Education : Bachelor's Degree in engineering, science, or technical field or equivalent, Master's Degree preferred.
* 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, Transfer from R&D to Production, Post Market Surveillance, supplier quality.
* Experience in resource planning and management. Knowledge of project management methods and estimation techniques.
* Experience with outsourcing and negotiation with 3rd parties.
1. Skills
* Excellent communication skills, both orally and in writing.
* An energetic and driven professional with organizational talent and ready 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 environment.
* Process & Results oriented.
2. 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, risk management, validation, verification, systematic problem solving, and statistical analysis.
* Experience with root cause investigation methodologies.
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