• Team member representing Quality on new product development and sustaining engineering projects.
• Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Business Unit requirements.
• Develop quality plans, execute inspection & testing activities and work further with Manufacturing on the transfer of quality requirements.
• Promotes the use of statistics in the testing and control of quality.
• Supports R&D in device product/process development and production activities, including the following:
• Develops and/or reviews product/process verifications/validation or test plans (protocols and reports).
  
• Develops and/or reviews product/process specifications and requirements.
  
• Develops and/or reviews product reliability specifications/predictions; reliability test activities.
  
• Conducts/coordinates risk management activities including review failure mode effects analysis (FMEA), hazard analysis, fault tree analysis (FTA) and/or risk or statistical analysis.
• Participates in product or process design and change activities, including design reviews.
• Provides technical support for product quality attributes/decisions.
• Coordinates selected verification/validation activities (e.g., toxicology/biocompatibility, sterilization validation, etc.) with external suppliers.
• Applies Design to Cost and Design for Manufacturability methods to support project leader in achievement of project objectives. 
• Provides quality-related technical support to Unit Business(es). 
• Contributes to assembly and maintenance of Design History Files (DHF).
• Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System. 
• Creates, implements changes to, and maintains controlled documents as needed (e.g., SOPs, Specifications, Methods, etc.) to ensure strict compliance of R&D functional operation with ISO 13485/FDA QSR Quality System.
• Ensures a safe, healthy and environmentally-friendly workplace by observing Company’s procedures and ISO 14001 regulations. Actively involved in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement and reduction of resource materials.
  

• Bachelor’s Degree in Electrical, Mechanical or Industrial Engineering or equivalent (Mechanical, Biomedical, Polymer Engineering, Natural Sciences).
• At least five years’ work experience in a Product Development/Design Assurance function in regulated environment (medical devices/Diagnostic instrumentation industry).
• Experience in the design and development of products in accordance with ISO 13485 guidelines.
• In depth know-how and experience of quality techniques: Six Sigma Blackbelt, Six Sigma methods such as DFSS, DMAIC, DoE, FMEA, etc.
• Experience in manual assembly processes, particularly those involving silicone and PU molded/extruded parts and assemblies. involving gluing and modular automation.
• Experience in the entire Design life-cycle and  Phase-Gate development process.
• cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC.
• Statistical methods.
• SAP (Manufacturing Execution Systems / MES will be an advantage).