Quality Manager

Boston Scientific Gruppe; Penang; On-site; MYR 120,000 - 180,000; Full time

Job summary

A leading global medical technology organization seeks a Quality Engineering Manager to develop high-performance teams. The role ensures compliance with standards while fostering continuous improvement initiatives across the Corporation. Ideal candidates will possess extensive managerial experience and expertise in quality management within the medical industry.

Qualifications

• Over 10 years in a managerial role within medical production.
• Expertise in ISO 13485 and 21 CFR 820.
• Minimum 3 years managing engineers and technicians.

Responsibilities

• Develops and manages quality engineering teams focused on compliance and product quality.
• Leads product quality decisions and customer complaint investigations.
• Executes plans for major project segments from a quality perspective.

Skills

Leadership

Quality Management

Risk Mitigation

Customer Focus

Knowledge of ISO

Education

Bachelor of Science in Biomedical Science or Engineering

Job description

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• 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

Requirements

• Minimum Bachelor of Science in Biomedical Science or equivalent degree or Engineering Degree.
• Minimum 10 years of experience working in managerial capacity within a production environment in medical industry.
• Well versed in ISO 13485 and 21 CFR 820 requirements.
• Minimum 3 years of experience managing engineers and technicians.
• Knowledge of statistics and understanding of Finance 101 will be 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.

Job Segment: Biomedical Engineering, Risk Management, Medical Technology, Quality Engineer, Engineering, Finance, Healthcare, Customer Service