Client Background: Medical device manufacturing industry

Tenure: Permanent

Location: Batu Kawan, Penang

Headcount: 1

Purpose Statement

Demonstrates strong commitment to the Quality Policy with a focus on patient safety and product quality through daily execution of robust quality practices and maintenance of an effective quality system. Ensures full understanding and compliance with all applicable quality regulations. Responsible for ensuring the team is aware of quality commitments, remains current with training requirements, and complies with all regulatory and quality system requirements governing their work.

Job Description

• Develops and manages a high-performance quality team with strong focus on customer needs, regulatory compliance, product quality, and risk mitigation
• Holds responsibility and independent authority to make decisions related to product quality, including disposition of non-conforming products
• Assists in and/or manages functional deliverables and ensures technical excellence in product or technical development activities
• Participates in customer complaint investigations for areas under their responsibility
• Acts as a leader or subject matter expert in Quality System Regulations (QSR) and ISO/MDD standards within the team, promoting best industry practices and making sound quality decisions, escalating critical matters to the Site QA Director when required
• Develops, directs, and executes quality plans for major segments of complex projects
• Reviews and approves operational, test, and validation data to establish technical specifications and performance standards for new or modified products and processes
• Leads the development and implementation of new techniques and initiatives to enhance the Quality Management System on-site and, where applicable, across the organization
• Plays a key role in developing staff on new quality initiatives and supporting understanding and rollout across the department or site
• Serves as an effective people manager, fostering a motivated and high-performing team aligned with quality and departmental objectives
• Assists in budget development and monitors departmental spending
• Collaborates with EHS to identify significant environmental impacts and establish goals and targets related to environmental performance
• Is familiar with and supports internal auditing processes
• Establishes and supports a culture of continuous improvement aligned with the Quality Policy, Quality System, and applicable regulatory requirements

Job Requirements

• Bachelor’s Degree in Engineering, Mathematics, Statistics, Analytics, or other Science-related disciplines
• Minimum 10–12 years of working experience in a Quality System regulated organization (ISO 9001 / ISO 13485)
• Experience in Distribution Quality, Operations Quality, or Quality Systems is a strong advantage
• Strong people leadership and team management skills
• Ability to lead and promote a positive and high-performance work culture
• Excellent influencing and communication skills
• Strong team player with a positive and results-driven mindset
• Demonstrated leadership capability in driving issue investigation and resolution
• Experience in the medical industry is an added advantage