Purpose Statement Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
Key Responsibilities Mentors Engineers on Problem Solving Tools
Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
Drives Problem Solving Culture within own area Leads projects within own team or sepcialised projects at department level SME for Medical Device Related Standards and Regulations
Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
Identify Distribution supply chain including Inbound as well as outbound process defects (scrap, nonconforming material) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions.
Own and/ or provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Demonstrates and actively promotes highest levels of professional QA engineering discipline
Lead and drive Quality related initiatives/ project including enabling new capabilities
Reviews and approves CN to ensure compliance and adequacy of process establishment as well as change made to the process.
Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction.
Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and organization objectives.
Gives technical guidance to Quality Engineers, Quality Technician and other functional department key stakeholder.
Familiar with the Certification Body audit such as ISO 13485 / MDSAP/ GDPMD.
Job Requirements: Candidate required process at least Bachelor Degree in any Engineering course, Mathematic, Statistic and Analytic or other Science related course. At least 8 -10 years of working experience in Quality environment preferably in Quality System regulated organization - ISO 9001/ ISO 13485. Experience in Distribution Quality / Operations Quality / Quality System will be with added advantage. Skill: Excellent Influencing and communication skill, good team player, positive attitude to excel work toward success, problem solving skill and possess leadership dependencies to be able to lead team for issue investigation.Project Lead in Cross Function and Area Level Projects As lead to small Group of junior engineer
