Quality Engineer

Key Responsibilities:

• To monitor and ensure the product quality is complying to specification and product quality standards

• Initiate continual improvement activities based on external (customer and supplier) and internal feedback.

• Responsible for quality assurance activities and documentation to meet ISO & regulatory requirements

• Work with cross functional team during mold evaluation to ensure the compliance of products and prepare the evaluation reports and improvement actions for closure.

• Participate in pre-customer drawings and technical requirements review, and establish/define Inspection & Testing criteria for the products/processes

• Evaluate customer quality standards, tolerances, measurement benchmarks, and measurement fixture requirements.

• To prepare the acceptance/reject/limit samples for production references.

• Handle customer & supplier complaints and ensure complaints are well addressed

• Monitor and ensure the effectiveness of the ECN, and prepare PPAP documents (including: PFMEA, Control plan, SCR, etc) and process validation (OQ & PQ)

• Any other duty assigned by superior.

Requirements:

• Bachelor's Degree in Engineering, Quality Management, Manufacturing, or related field with minimum 2 years of working experience in a manufacturing environment.

• Knowledge of Quality Management Systems (QMS) and ISO 13485 requirements. Experience in the medical device industry will be an added advantage.

• Experience in New Product Introduction (NPI), mold evaluation or injection moulding processes, lab testing experience in equipment GCMS, LCMS will be an added advantage.

• Familiar with quality tools and methodologies such as 8D, 5 Why Analysis, Fishbone Diagram, FMEA, Control Plan, SPC, CAPA, and PPAP.

• Experience in handling customer complaints, supplier quality issues and corrective/preventive actions.

• Ability to interpret engineering drawings, specifications, and customer technical requirements.

• Knowledge of process validation activities such as IQ/OQ/PQ is preferred.

• Strong analytical, problem-solving and root cause analysis skills.

• Good communication and interpersonal skills to liaise with customers, suppliers and cross-functional teams.

• Knowledge of 5S practices and continuous improvement methodologies.