Quality Manager (DC)

Boston Scientific; Penang; On-site; MYR 80,000 - 120,000; Full time

Job summary

A global medical technology leader is seeking a Quality Engineering Manager in Penang, Malaysia. The role involves developing a high-performance quality engineering team, making critical quality decisions, and ensuring compliance with industry standards. The ideal candidate has a Bachelor's Degree in Engineering or a related field, with a minimum of 10-12 years of experience in a quality system regulated organization. Experience in the medical industry is a significant advantage. This position offers opportunities for leadership and professional growth.

Qualifications

• Minimum 10-12 years working experience in Quality System regulated organization - ISO 9001/ISO 13485.
• Experience in Distribution Quality, Operations Quality or Quality System is a plus.
• Experience in the medical industry is an added advantage.

Responsibilities

• Develop and manage a high-performance quality engineering team focused on customer needs and product quality.
• Make decisions related to product quality and investigate customer complaints.
• Lead and implement enhancements to the Quality Management System.

Skills

Leadership

Communication

Teamwork

Quality Management

Problem Solving

Education

Bachelor's Degree in Engineering, Mathematics, Statistics, or related Science

Job description

Purpose Statement

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complieswith all the regulations governing the quality systems. Ensurestheir team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Job Description

• Develops and manages a high-performance quality engineering team with a focus on customer needs, compliance, product quality, and risk mitigation.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Assists in and/or manages functional deliverables and ensures technical excellence for product or technical development.
• Participates in Customer Complaints investigation for areas under their control.
• Is viewed as a leader or expert in the areas of QSR and ISO/MDD standards within one's own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Site QA Director as the final arbitrator on critical quality decisions.
• Develops, directs and executes plans for major segments of complex projects from a quality perspective.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on-site and across the Corporation where possible.
• Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department/site.
• Is an effective people manager resulting in a motivated high performance team. Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and quality objectives.
• Assists in and/or completes the development of budgets and monitors spending.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Is familiar with the internal auditing process.
• To establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area.

Job Requirements

• Candidate required to possess at least Bachelor Degree in any Engineering course, Mathematic, Statistic and Analytic or other Science related course.
• Minimum 10-12 years working experience in Quality System regulated organization - ISO 9001/ ISO 13485.
• Experience in Distribution Quality / Operations Quality / Quality System will be with added advantage.
• Possess strong people leadership skill.
• Capable of leading and promoting positive work culture.
• Excellent Influencing and communication skill.
• Good team player and positive attitude to excel work toward success.
• Possess leadership dependencies to be able to lead team for issue investigation.
• Experience in the medical industry will be considered an added advantage.

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.