Quality Manager (DC)

Boston Scientific Gruppe; Penang; On-site; MYR 120,000 - 160,000; Full time

Job summary

A leading medical technology firm in Malaysia seeks a Quality Engineering Manager to develop and lead a high-performance team focused on compliance and product quality. The ideal candidate will possess a Bachelor's degree in Engineering and have a minimum of 10-12 years of experience in a regulated quality system environment. Strong leadership and communication skills are crucial, as is the ability to foster a positive and compliant workplace culture. Join us to transform lives through innovative solutions for patients.

Qualifications

• Minimum 10–12 years of working experience in a regulated Quality System organization.
• Experience in Distribution Quality / Operations Quality / Quality System is an added advantage.
• Experience in the medical industry is considered an added advantage.

Responsibilities

• Develop and manage a high-performance quality engineering team.
• Make decisions related to product quality, including non-conforming product disposition.
• Participate in Customer Complaints investigation.
• Establish goals around significant environmental impacts.

Skills

Strong people leadership skills

Excellent influencing and communication skills

Good team player with a positive attitude

Education

Bachelor's Degree in Engineering or related fields

Job description

Overview

Demonstrates commitment to the Quality Policy (patient safety and product quality) through daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all regulations governing the quality systems. Ensures their team is aware of their commitment to patient safety and product quality, current with training requirements, and compliant with all regulations governing their work.

Responsibilities

• Develop and manage a high-performance quality engineering team with a focus on customer needs, compliance, product quality, and risk mitigation.
• Have the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Assist in and/or manage functional deliverables and ensure technical excellence for product or technical development.
• Participate in Customer Complaints investigation for areas under their control.
• Serve as a leader or expert in QSR and ISO/MDD standards within their group, promoting best industry practices and making appropriate decisions daily, with the Site QA Director as final arbitrator on critical quality decisions.
• Develop, direct, and execute plans for major segments of complex projects from a quality perspective.
• Review and approve 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.
• Key to developing staff on new quality initiatives and assist in understanding and rollout of quality initiatives across the department/site.
• Act as an effective people manager, resulting in a motivated high-performance team, and be an influential team member fully motivated to achieve and demonstrate best practices in line with department and quality objectives.
• Assist in and/or complete development of budgets and monitor spending.
• Work with EHS to identify significant environmental impacts of Boston Scientific operations and establish goals and targets around significant environmental impacts.
• Be familiar with the internal auditing process.
• 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 must possess at least a Bachelor's Degree in Engineering, Mathematics, Statistics, Analytics, or other science‑related courses.
• Minimum 10–12 years of working experience in a regulated Quality System organization (ISO 9001 / ISO 13485).
• Experience in Distribution Quality / Operations Quality / Quality System is an added advantage.
• Strong people leadership skills.
• Capable of leading and promoting a positive work culture.
• Excellent influencing and communication skills.
• Good team player with a positive attitude and a drive to excel toward success.
• Leadership dependencies to lead a team for issue investigation.
• Experience in the medical industry is 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.

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