Key Responsibilities

• Lead, coach or support all stakeholders related to Customer Quality or Design Quality Assurance to ensure the compliance of QMS and regulatory requirements.
• Lead and/or manage customer enquiries, incidents investigation, complaint follow-up and root cause analysis to ensure problems can be timely solved, low risk to stakeholders and meeting both management & customer expectation.
• Act as customer technical contact point as appropriate on failure analysis or problem solving on product design or application.
• Quality management system setup, implementation and supporting offsite facilities.
• Coordinate and monitor the implementation of change control from product development to production stages per ERP and/or QMS database system. 
• Work closely with functional leaders to setup and improve the QMS system for alignment with medical industrial best practice.
• Work closely with technical departments for design risk analysis, validation or solutions on any issues related to the product/parts, process, equipment or tools as appropriate.
• Work closely with Project Team to review the issues, potential risk come from DV, PV, new project pilot run and drive relevant parties to implement corresponding solutions or corrective actions.
• Regular review, evaluate and/or audit projects deliverables, validation and testing protocol and/or records to ensure the compliance of quality management system and regulatory requirements. 
• Ad hoc assignment related to new medical device regulations, customer requirements, corporate initiatives or strategic programs.

Education and Experience required

• Bachelor’s degree or above in Engineering or Scientific disciplines.
• Minimum 2 years experiences in medical device industry related to quality, regulatory affairs, manufacturing or engineering.
• Qualified medical QMS internal auditor is preferred.
• Certified Quality professional – Six sigma black belt, CQE, CQA, CQM or equivalent is preferred.
• Good understanding of US, EU medical regulations and related industrial standards.
• Experience in QMS setup, implementation, audit and certification.
• Hand on experience in product life cycle stages, supply chain, manufacturing, customer services system setup.
• Experience in risk assessment, product and process validation, change control, ERP, statistical data analysis and report preparation to management.
• Strong leadership and project management skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Good problem solving, interpersonal skills and able to work effectively within a team in a fast-paced changing environment.
• Good analytical thinking and able to comprehend principles of engineering, physiology and medical device applications.
• Willing to travel to production facilities in China or overseas.
• Fresh graduates will also be considered as Assistant Engineer.
• Candidates with more experience and authority or broader exposure on QE/QA activities will be considered as Lead Engineer.
• Candidates with more experience and exposure on QA/QMS will be considered as Senior or Lead QA Engineer.
• Immediate available is preferred

Please apply with detailed CV, salary expected, available date and contact telephone number to us for selection by clicking "Apply Now."  All information collected would be used for recruitment purpose only.