we are looking for a Product Quality Engineer.
Job Responsibilities:
Facilitates operations performance monitoring, reporting, improvement and development, facilitates improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and Purchasing.
Conducts assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
Leads analysis of defects for determining dispositions of non-conformances, drives management of Non-Conformances (NC) and Quality Notifications (QN) and facilitates implementation of effective Corrective and Preventive Actions (CAPA) actions.
Handles non conformance events and investigations in the factory and guides material review board activities for non-conformance disposition management.
Facilitates timely quality engineering and quality assurance tasks, ensures manufacturing quality systems are maintained, handles single or complex process validation and process improvement activities, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
Possesses working knowledge of generic products/services and Quality Engineering and Continuous Improvement techniques, follows processes and operational policies in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others.
Acts as an advisor to subordinates to meet schedules and/or solve technical problems, develops and administers schedules and performance requirements, and may have budget responsibilities.
Cultivates effective relationships, demonstrating full understanding of area of specialization, demonstrates good working relationships with suppliers, and previous experience of participation in several New Product Introductions (NPIs).
Leads validation protocols, facilitates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities.
Utilizes advanced statistical analysis methods to interpret complex data trends, resolve a wide range of moderate complexity requests, and provide strategic insights for continuous enhancement of quality standards and process efficiency.
Discusses detailed, strategic quality metrics and reports with stakeholders, highlighting significant achievements, emerging trends, and actionable insights to drive advanced improvement initiatives and ensure regulatory compliance.
Delivers specialized advanced training programs on cutting-edge quality standards, advanced methodologies, and best practices, fostering alignment across functions and advancing excellence in operational practices at an expert proficiency level.
Cultivates effective relationships with internal/external partners and provides influence over projects and peer groups, demonstrating full understanding of area of specialization.
Requirements: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
Minimum required Experience:
Minimum 2 years of experience with Bachelor's in areas such as Quality Engineering, Safety Engineering, Process Engineering or equivalent OR no prior experience required with Master's Degree.
Previous experience from medical device companies- Must
This position is open to all candidates.