Senior QA Manager (Medical Device|ISO13485)

Full Time, onsite
MINDE Group
Johor Bahru, Malaysia

RM 16,000 - RM 21,000 / month

Apply on

Indeed MY

Availability Status

This job is expected to be in high demand and may close soon. We’ll remove this job ad once it's closed.

Original

Simplified

Position Summary

The Senior QA Manager / QA Director is responsible for leading and overseeing the Quality Assurance function for company. This role plays a key part in strategic planning and decision-making at the executive level, ensuring alignment with the company’s vision, mission, and long-term objectives. The Senior QA Manager / QA Director will develop, implement, and optimize quality systems and control programs to maintain and enhance product quality and regulatory compliance.

Main Responsibilities and Authorities

Develop and define the overall quality strategy, including setting policies, objectives, and standards for quality assurance.
Implement, maintain, and improve the company’s Quality Management System (QMS) in accordance with regulatory, customer, and internal requirements.
Lead the QA team to ensure product quality compliance with medical device regulations, company policies, and customer standards.
Establish and monitor standards for incoming inspection, process control, and final goods inspection.
Ensure processes and products conform to regulatory requirements and specifications, driving continuous improvement based on findings.
Manage and resolve customer complaints, driving improvements and ensuring proactive communication with stakeholders.
Approve quality-related system documents, CAPA (Corrective and Preventive Actions), and nonconformance reports.
Drive supplier quality management, collaborating with engineering and procurement teams for supplier assessment and improvement.
Conduct internal audits and support external audits, including customer and regulatory inspections.
Facilitate management reviews, ensuring effective communication and alignment on quality objectives.
Provide training to quality department personnel and enhance quality awareness throughout the organization.
Transition the focus from quality inspection to design and process quality through professionalizing systems and people.
Implement and maintain document control programs, and interface with global customers to develop vendor programs for quality systems.
Ensure compliance with Health, Safety, and Environmental (HSE) procedures within areas of responsibility.
Undertake additional responsibilities as assigned by the General Manager.

Qualifications:

Diploma/Bachelor’s degree or higher, preferably in Engineering or Science.
Minimum of 10 years of management experience in quality assurance, preferably within the medical device industry.
In-depth knowledge of production processes and quality control methodologies.
Strong leadership abilities with a strategic and business-oriented mindset.
Expertise in electronic production procedures.
Excellent data analysis and problem-solving skills.
Proficiency in English (oral and written) and strong computer skills.
Regulatory knowledge including: FDA QSR Part 820 (Class I and Class II Medical Devices), MDSAP (Medical Device Single Audit Program), ISO 13485 (current version), Medical Device Act 2012 (Act 737)