This role is responsible for Outgoing Quality Control (OQC) and/or In-Process Quality Control (IPQC) activities, including product quality inspection, qualification, and resolution of quality issues. The QA Engineer supervises QA Operators, ensures compliance with quality standards, and drives continuous improvement initiatives across cross-functional teams to enhance product quality and process effectiveness. The role also involves developing, maintaining, and improving in-process quality control standards and procedures, and planning and coordinating the qualifications of new materials and equipment.
Responsibilities
Develop and implement procedures, processes, and methods promoting prevention techniques and continuous improvement within Knowles Electronics and with external customers and suppliers
Analyze quality data and trends to improve inspection, testing processes, and product quality
Establish and maintain outgoing quality control plans, including inspection and test methods, sampling plans, acceptance criteria, and related procedures to ensure effective outgoing product quality control
Monitor and analyze outgoing quality performance indicators, including DPPM and defect trends, and drive continuous improvement initiatives to achieve established quality objectives
Evaluate new materials and qualify machines or modifications carried out in the manufacturing line that requires QA approval and ensure that these introductions or changes have no adverse effect on the product quality
Support new product introduction (NPI), new model qualification, design optimization, and process change activities to ensure product quality requirements are adequately evaluated and verified prior to implementation
Perform audits of management systems and operational procedures and customer audit prior to customer visit/audit throughout the organization
Report results and recommend opportunities for improvement
Develop, implement, maintain, and improve procedures consistent with certification of QMS, EMS, and OSH Management Systems/Standards
Establish and maintain procedures consistent with certification of QMS, EMS, and OSH Management Systems/Standards
Maintain and comply with procedures that are aligned with certification of QMS, EMS, and OSH Management Systems/Standards
Responsible for process and software validation in accordance with applicable regulatory and quality system requirements, including but not limited to ISO 13485 and FDA 21 CFR Part 820
Support risk assessment activities related to process, software, and product quality in alignment with applicable regulatory and quality system requirements
Oversee DHR release, ensuring documentation completeness, traceability, and readiness for audit and product release
Act as the customer quality interface between the factory and customers on quality-related matters and during customer audits, working closely with internal cross-functional teams to ensure timely closure of customer complaints
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Liaise with customers through Sales offices on quality-related matters
Coordinate with other departments regarding customer complaints, quality of parts, inspection processes and product quality problems and follow up on the corrective action and its implementation status
Work with field and cross-functional teams to investigate customer complaints and provide timely 8D reports to customers
Initiate defect containment activities through suspending the delivery/warehousing/production where deemed necessary
Manage nonconforming products, including containment, investigation, material disposition, corrective and preventive actions, and closure of related quality issues
Coordinate verification of customer returns and any necessary rework, and communicate with Customer Service to ensure closure
Issue QA reports to communicate the customer quality situation, where applicable
Identify important quality problems and work with the team for process compliance improvement
Prepare and maintain QAP, Work Instructions, Procedures, Deviations, and other QA-related documents, including the implementation of ECR activities, and subsequently revise and update changes in accordance with document control procedures
Timely issue of QA Monthly Report to inform the quality situation of each process to the related department
Provide training for subordinates and contractors (if any), in Quality Management Systems, Environmental and Occupational Safety and Health Management Systems, where necessary
Ensure that quality activities performed by incumbent and subordinates (if any) fall in line with MS ISO 9001, ISO 13485, ISO 14001, and ISO 45001 procedures
Carry out assignments and assist superiors in overall quality assurance activities as per required
Requirements
Bachelor's Degree in Science or equivalent
3-5 years of relevant experience
Strong knowledge of semiconductor manufacturing processes and quality management systems, including ISO 9001, ISO 13485, ISO 14001, and ISO 45001 (Exposure to these standards is preferred for fresh graduates)
Nice to have:
Knowledge of QC 7 Tools, SPC, FMEA, problem-solving methodologies and statistical analysis techniques (Training will be provided where necessary)
