Quality Manager (Distribution Center)

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 120,000 - 180,000; Full time

Job summary

A leading medical device company in Penang is seeking a Quality Engineering Leader to develop and manage a high-performance quality engineering team. The ideal candidate should possess a Bachelor's degree and at least 10-12 years of experience in a regulated quality system environment, specifically ISO 9001/ISO 13485. Responsibilities include making critical quality decisions, leading teams in investigations, and enhancing quality initiatives. This role emphasizes strong people leadership and communication skills.

Qualifications

• Minimum 10-12 years working experience in a quality system regulated organization.
• Experience in Distribution Quality / Operations Quality / Quality System is advantageous.
• Experience in the medical industry is a plus.

Responsibilities

• Develops and manages a high-performance quality engineering team.
• Has authority to make decisions related to product quality.
• Participates in customer complaints investigation.
• Promotes awareness of best industry practices.

Skills

Strong people leadership

Excellent influencing and communication skills

Team player

Positive attitude

Education

Bachelor Degree in Engineering, Mathematics, Statistics, Analytics or related field

Job description

Demonstrates commitment to the Quality Policy (patient safety and product quality) through daily execution of sound quality practices and maintenance of an effective quality system. Understands and complies with all regulations governing the quality systems. Ensures 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 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 QSR and ISO/MDD standards within their 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 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, Mathematics, Statistics, Analytics 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 dependency to be able to lead team for issue investigation.
• Experience in the medical industry will be considered an added advantage.