Design Quality Engineer SME

• Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline;​
• 10+ years of professional experience in medical device regulatory Quality systems EU MDR, US FDA 510(k) and closely working R&D, Regulatory Affairs organizations​
• Strong proven experience in simplifying/reviewing DHFs, Design requirements, IFUs, Risk management , V&V activities etc.​
• Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC 60601-1, ISO 14971-1, IEC 62366-1, ISO10993-1, and MEDDEV 2.7/4.​
• Experience with systems for quality management, product development, and follow-up of procedures​
• Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.)​
• Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan​
• Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc.​
• Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle​
• Performs independent technical assessment on product quality performance and post-market product quality analysis​
• Can Lead quality related problem solving and root cause analysis during design and manufacturing​
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required​
• Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone etc.)​

Personality Characteristics

• Compliance focused​
• Be able to handle ad-hoc changes in priority/planning and independently.​
• Be able to think from customer expectation perspective​
• Be able to work in different teams simultaneously​
• Communicative & disciplined team worker.​