QA ENGINEER

Sunningdale Tech Penang Sdn Bhd; Batu Kawan; On-site; MYR 60,000 - 100,000; Full time

Job summary

Sunningdale Tech Penang Sdn Bhd is seeking a Quality Assurance Engineer to oversee the implementation and maintenance of the QMS across plastic injection molding and related processes. You will lead IPQC activities, drive continuous quality improvements, and coordinate with Process Engineers and CQEs to resolve quality issues.

The ideal candidate has 5+ years in QA within plastics or medical device manufacturing, and a strong knowledge of ISO 13485 and ISO 9001.

Qualifications

• Degree in Engineering, Quality Management, Manufacturing, or related field.
• 5 years plus experience in Quality Assurance within plastic injection molding or medical device manufacturing.

Responsibilities

• Ensure quality system requirements are implemented, reviewed, and maintained per customer and regulatory standards.
• Maintain effective QA systems to ensure products meet customer specifications.
• Lead QA activities for plastic injection molding, lacquering, printing, laser etching, and sub-assembly processes.
• Guide IPQC team to perform daily inspection activities per procedures.
• Monitor SPC implementation to ensure process control and product quality.
• Develop ECOs, PIPs, PMPs, and WIs for related processes.
• Review QA reports, inspection records, and documentation.
• Participate in customer complaint investigations and root cause analysis for corrective actions.
• Support quality issue investigations with Process Engineers and CQEs.

Skills

Quality Assurance

Statistical Process Control (SPC)

Root Cause Analysis

FMEA

CAPA

ISO 13485

ISO 9001

Education

Engineering / Quality Management degree

Tools

MSA

8D Problem Solving

CAPA system

Job description

Responsible for ensuring effective implementation and maintenance of the Quality Management System (QMS) in compliance with customer requirements, regulatory standards, and applicable legal requirements. Manage QA activities for plastic injection molding, secondary processes, and sub-assembly operations to ensure products meet quality specifications through effective process control, quality improvement, and compliance activities.

Job Responsibilities :

Ensure quality system requirements are implemented, reviewed, and maintained in accordance with customer requirements, regulatory requirements, and applicable legal standards.

Ensure effective and continuous Quality Assurance systems are maintained to ensure products delivered conform to customer specifications.

Manage QA activities for assigned processes including plastic injection molding, lacquering, printing, laser etching, and sub-assembly operations.

Lead and guide the IPQC team to ensure daily inspection activities are performed effectively and according to established procedures.

Maintain and monitor SPC implementation to ensure process control and product quality consistency.

Develop, review, and implement Engineering Change Orders (ECO), Part Inspection Plans (PIP), Part Management Plans (PMP), and Working Instructions (WI) for related processes.

Ensure inspection methods, quality controls, and documentation are properly established to support smooth production operations.

Review, verify, and approve QA reports, inspection records, and documentation prepared by QA Supervisors, Leaders, and Inspectors.

Participate in customer complaint investigations and conduct root cause analysis to identify effective corrective actions.

Support internal and external quality issue investigations together with Process Engineers and Customer Quality Engineers (CQE).

Analyze QA rejection trends, follow up on improvement actions with process owners, and present quality performance updates to management.

Review non-conforming products and determine appropriate disposition according to quality requirements.

Monitor affected processes and coordinate with internal suppliers and internal customers to ensure quality issues are resolved effectively.

Provide quality information and recommendations to Production, Engineering, Tool Room, and related departments for continuous improvement.

Ensure inspection records, quality documents, and product traceability records are properly maintained and readily available.

Support customer audits, internal audits, and quality system audits; prepare responses for audit findings and assist in audit closure activities.

Ensure compliance with ISO 13485, ISO 9001, customer requirements, and company QEHS management system requirements.

Recommend improvements to quality systems, procedures, and processes to enhance effectiveness.

Train and develop QA team members to improve competency and ensure effective execution of quality activities.

Escalate unresolved quality issues to the QA Manager / Assistant QA Manager for further action.

Perform any other duties and responsibilities assigned by the Head of Department from time to time.

Job Requirements :

Degree in Engineering, Quality Management, Manufacturing, or related field.

5 years above experience in Quality Assurance within plastic injection molding or medical device manufacturing industry is preferred.

Knowledge of ISO 13485, ISO 9001, and Quality Management System requirements.

Familiar with quality tools such as SPC, MSA, FMEA, 8D, CAPA, and root cause analysis.

Experience in customer complaint handling, audit support, and non-conformance management.

Knowledge of plastic injection molding processes and secondary processes is an added advantage.

Good problem-solving, analytical, and communication skills.

Able to work independently and collaborate effectively with cross-functional teams.

Unlock job insights

Machinery & Automation 101-1,000 employees

Product & Services

Our main products are injection molding precision plastic parts and complete assembly of ink cartridges by applying full auto machines. We also provide spray printing work for our customers.

Product & Services

Our main products are injection molding precision plastic parts and complete assembly of ink cartridges by applying full auto machines. We also provide spray printing work for our customers.

What can I earn as a Quality Assurance Engineer