Quality Engineer

MeHow Medical (M) Sdn Bhd; Simpang Ampat; On-site; MYR 48,000 - 72,000; Full time

Job summary

MeHow Medical (M) Sdn Bhd in Malaysia seeks a Quality Assurance professional with at least 2 years in manufacturing to ensure product quality and drive continuous improvements. You will work with cross-functional teams on mold evaluations, accept/reject criteria, and regulatory documentation to meet ISO13485 and customer requirements.

The role emphasizes handling customer/supplier quality issues, implementing PPAP, PFMEA, and CAPA, and validating processes with IQ/OQ/PQ.

Qualifications

• Bachelor's degree in engineering or related field with at least 2 years in manufacturing.
• Knowledge of QMS and ISO 13485; medical device experience is a plus.
• Experience in NPI, mold evaluation or injection moulding; lab testing equipment GCMS/LCMS a plus.
• Familiar with 8D, 5 Why, Fishbone, FMEA, Control Plan, SPC, CAPA and PPAP.
• Experience handling customer and supplier quality issues and CAPA actions.

Responsibilities

• Monitor product quality to ensure compliance with specifications and standards.
• Initiate continual improvement based on feedback from customers and suppliers.
• Lead quality assurance activities and documentation to meet ISO/regulatory requirements.
• Collaborate with cross-functional teams during mold evaluation to ensure product compliance.
• Define inspection and testing criteria for products/processes from customer requirements.
• Evaluate customer quality standards, tolerances, and measurement fixtures.
• Prepare acceptance/reject/limit samples for production references.
• Handle customer and supplier complaints and ensure effective resolutions.
• Oversee ECN effectiveness and prepare PPAP documents (PFMEA, Control Plan, SCR, etc.).
• Support process validation (IQ/OQ/PQ) and other duties as assigned.

Skills

Root cause analysis

8D problem solving

FMEA

CAPA

Control plan

SPC

Cross-functional teamwork

Documentation

Quality tools knowledge

Communication skills

Education

Bachelor's degree in Engineering, Quality Management, Manufacturing, or related field

Tools

GCMS

LCMS

Job description

• 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, labtestingexperienceinequipmentGCMS,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.

Mehow has always focused on providing one-stop services to the world’s leading medical device manufacturers. We have rich experience in the production of liquid silicone rubber (LSR), plastic and LSR/thermoplastic two-component products. Mehow headquarter is in Shenzhen, China. First factory was set up in Shenzhen in year 2010. The first oversea factory was set up in Penang, Malaysia in year 2016.

With strong production and technical knowledge, Mehow has achieved seamless integration with customer projects, from conceptual design, production engineering, prototyping, to finished product assembly. Through continuous improvement and upgrading of our strength, we continue to provide customers with high value-added services and highly rigorous process control to meet customers’ constant pursuit of high quality. Through close cooperation with customers in all aspects, we have achieved shorter time-to-market, reduced project management risk and better cost control for customers.

Mehow can better embrace the ever-changing and higher-end market demand by accumulating a large amount of experience and improving production and technical strength. We always adhere to and operate in accordance with the requirements of ISO9001 & ISO13485 system, ensuring every process is effectively controlled, and doing the best to provide customers with high quality products.

Mehow has always focused on providing one-stop services to the world’s leading medical device manufacturers. We have rich experience in the production of liquid silicone rubber (LSR), plastic and LSR/thermoplastic two-component products. Mehow headquarter is in Shenzhen, China. First factory was set up in Shenzhen in year 2010. The first oversea factory was set up in Penang, Malaysia in year 2016.

With strong production and technical knowledge, Mehow has achieved seamless integration with customer projects, from conceptual design, production engineering, prototyping, to finished product assembly. Through continuous improvement and upgrading of our strength, we continue to provide customers with high value-added services and highly rigorous process control to meet customers’ constant pursuit of high quality. Through close cooperation with customers in all aspects, we have achieved shorter time-to-market, reduced project management risk and better cost control for customers.

Mehow can better embrace the ever-changing and higher-end market demand by accumulating a large amount of experience and improving production and technical strength. We always adhere to and operate in accordance with the requirements of ISO9001 & ISO13485 system, ensuring every process is effectively controlled, and doing the best to provide customers with high quality products.