QA Engineer

Kelpac Medical; Gelang Patah; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading company in the medical device sector is seeking a Quality Assurance Manager to oversee quality inspections and ensure compliance with ISO standards. The role involves leading investigations into non-conformances, maintaining documentation, and promoting quality awareness across the organization. Candidates should possess a relevant degree and have at least 3 years of experience in quality assurance within a manufacturing environment.

Qualifications

• Minimum of 3 years in product quality assurance within a manufacturing environment.
• Experience in the medical device industry and cleanroom environment is highly advantageous.
• Strong understanding of quality management systems (QMS), including ISO 13485 and ISO 9001.

Responsibilities

• Oversee all quality inspections, including in-process and final quality control.
• Lead cross-functional teams in investigating customer complaints and non-conformances.
• Maintain accurate documentation of inspection results and quality scorecards.

Skills

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor’s degree in Engineering, Applied Science, Quality Management

Tools

Microsoft Office

Job description

1.1 To support the HOD in ensuring that the quality system requirements and processes are effectively established, fully implemented, and maintained in accordance with relevant ISO QMS, GMP, and/or QSR requirements.

1.2 Responsible for overseeing all quality inspections, including in-process quality control, final quality control, incoming quality control, investigations, and corrective actions related to customer complaints or non-conforming products. Provide guidance to QC Technicians and Inspectors on quality control and assurance practices.

1.3 Monitor product quality by enforcing proper process controls and implementing the quality system in manufacturing to ensure full compliance with specifications.

1.4 Lead cross-functional teams in investigating customer complaints or non-conformances identified through audits or external sources. Conduct root cause analysis, perform risk assessments, and implement corrective and preventive actions (CAPA) to ensure compliance and continuous improvement.

1.5 Maintain accurate documentation of inspection results, test data, and quality scorecards.

1.6 Ensure control and maintenance of quality and documentation procedures.

1.7 Participate in internal and external audits by preparing documentation, assisting in audit activities, and supporting the audit team.

1.8 Promote awareness of regulatory and customer requirements throughout the organization in support of the HOD.

1.9 Manage validation processes and products by analyzing validation data and reviewing validation protocols (IQ, OQ, PQ).

1.10 Perform any additional responsibilities assigned by superiors within the agreed timeframe.

Job Requirements / Qualifications

• Educational Background: Bachelor’s degree in Engineering, Applied Science, Quality Management, or equivalent.
• Experience: Minimum of 3 years in product quality assurance within a manufacturing environment; experience in the medical device industry and cleanroom environment is highly advantageous.
• Strong understanding of quality management systems (QMS), including ISO 13485 and ISO 9001.
• Knowledge of ISO 13485, GMP, and FDA 21 CFR Part requirements is preferred.
• Strong interpersonal, analytical, and problem-solving skills.
• Proactive, resourceful, able to multitask, and work independently.
• Good communication skills in English and Bahasa Malaysia, both written and verbal.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) for data analysis and reporting.

Additional Information

Interested candidates are encouraged to apply and include relevant details that support their suitability for this role.