Associate Quality Manager

Boston Scientific; George Town; On-site; MYR 120,000 - 180,000; Full time

Job summary

A leading company in medical technology is seeking a senior quality manager to oversee operations and ensure product quality. This role involves leading teams, managing compliance, and driving continuous improvement in line with industry standards. Candidates should have significant experience in manufacturing quality, preferably in the medical device sector.

Qualifications

• Minimum 10 years' experience in manufacturing or operations quality.
• Experience in medical device industry preferred.
• Strong leadership and people management skills.

Responsibilities

• Ensure compliance with patient safety and product quality.
• Lead and motivate teams to achieve high performance.
• Manage product quality decisions and corrective actions.

Skills

Interpersonal Skills

Problem-Solving

Communication Skills

Leadership

Process Validation

Education

Degree in Engineering or Science

Job description

Key Responsibilities

• Ensure all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements, and understand and comply with all regulations governing their work.
• Coordinate work activities within various teams and ensure adequate resources are available to meet customer expectations.
• Maintain and enhance cross-functional/site team relationships.
• Lead and motivate the team to achieve high performance and align with department and Strategic Quality Planning (SQP) objectives.
• Provide direction and support to subordinates based on policies and management guidance.
• Perform and oversee performance appraisals for all reporting staff.
• Manage staff holidays and ensure sufficient coverage during shutdown periods.
• Select appropriate problem-solving techniques and make solid engineering and quality assurance recommendations.
• Make independent decisions related to product quality, including disposition of non-conforming products.
• Identify manufacturing process defects and assist in root cause analysis and corrective actions.
• Participate in customer complaints investigations and laboratory investigations such as Out of Specification (OOS).
• Support the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Promote awareness of QSR and ISO/MDD standards within the team and support best industry practices, with final decisions guided by the Quality Engineering Manager or Site QA Director.
• Review and approve operational, test, and validation data to establish technical specifications and performance standards.
• Collaborate with EHS to identify environmental impacts and establish related goals.
• Engage with suppliers, other engineering disciplines, and customers as needed.
• Familiar with the internal auditing process.

Requirements

• Minimum Degree in Engineering or Science.
• At least 10 years of experience in manufacturing or operations quality; experience in the medical device industry is preferred.
• Required skills include good interpersonal, problem-solving, communication skills, process validation, and leadership in people management.
• Experience in product transfer is an advantage.

About Us

Boston Scientific has been a global leader in medical technology for over 40 years. Our mission is to transform lives through innovative medical solutions that improve patient health. Join us to make a difference worldwide and locally.