Senior Product Quality Engineer

The SeniorProduct Quality Engineer will be based at Kallang, Singapore. Mainly responsible to maintain quality engineering programs, standards and improvements within the organization.

Job Responsibilities

• Participate actively on transferring of new projects from new customer and supporting to set up the NPI product line
• Interface with production , process and test engineering to ensure that products are consistently produced and controlled as per Good Manufacturing Practice (GMP)
• Establish and maintain Quality Control Plan , Risk Management Plan & Report, Device Master Record, FQA Critical component checking plan of the product
• Interface with customers on technical and quality issues and improvement initiatives and provide failure analysis and corrective action reports upon customers request
• Responsible for managing customer audits and regulatory and compliance agency audits
• Responsible for authorizing the released of final products to customer and training to FQA personnel and Product Quality Engineering Assistant
• Ensure that the manufactured and shipped products are in compliance with international industrial standards and customer requirements
• Follow up on quality issues identified to ensure corrective actions are in place and effective.
• Work closely with planner, PA, test and process engineers to effectively support for daily manufacturing activities and improve yield
• Participate in internal and external audits of QMS
• Participate in MRB (Material Review Board) review process to make sure timely turnaround of nonconformance material disposition, rework and closure
• Provide factory support to identify and resolve issues associated with purchased parts , materials and manufacturing
• Other relevant duties as assigned

Job Requirements

• Degree in Mechanical Engineering/Electrical Electronics Engineering/Manufacturing Process Technology or relevant field
• At least 5 years of manufacturing experience in similar role
• Familiarity in ISO 13485 Quality System Requirements and FDA CFR Part 820 regulations will be an added advantage
• Able to interpret within established procedures and practices as well as exercise independent judgment in complex situations