QA Manager(Medical Device/Plastic Molding)

Job Summary:

The QA Manager is responsible for overseeing the quality assurance functions in medical device and plastic injection molding manufacturing. This role ensures compliance with industry standards, regulatory requirements, and customer specifications, driving continuous improvement and maintaining high-quality production processes.

Key Responsibilities:

• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements specific to medical devices and plastic injection molding.
• Lead internal and external audits, including FDA, ISO, and customer audits.
• Monitor and update quality policies, procedures, and documentation as required.
• Establish and enforce quality control procedures for raw materials, in-process production, and finished products.
• Work closely with manufacturing, engineering, and supply chain teams to address quality issues and drive corrective actions.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA).
• Monitor and improve process validation, including IQ, OQ, and PQ for medical devices.
• Develop and maintain supplier quality standards, ensuring compliance with industry regulations.
• Conduct supplier audits and manage supplier corrective actions.
• Collaborate with procurement to ensure supplier qualification and ongoing quality performance.
• Manage non-conformance reports (NCR) and customer complaints effectively.
• Oversee product certifications and regulatory submissions when required.
• Drive continuous improvement initiatives using Six Sigma, Lean Manufacturing, and statistical process control (SPC).
• Develop and deliver training programs for employees on quality standards, best practices, and regulatory compliance.
• Foster a quality-focused culture within the organization.

Requirements:

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum of 5-8 years of experience in quality management within medical device or plastic injection molding manufacturing.
• Strong knowledge of FDA regulations, ISO 9001, and GMP.
• Experience with process validation, CAPA, SPC, and root cause analysis.
• Proficiency in quality tools such as FMEA, 8D, PPAP, and MSA.
• Excellent leadership, problem-solving, and communication skills.

Job Type: Full-time

Pay: RM10,000.00 - RM15,000.00 per month

Benefits:

• Professional development

Schedule:

• Monday to Friday

Supplemental Pay:

• 13th month salary
• Performance bonus

Work Location: In person

Expected Start Date: 03/31/2025