Quality Manager Manufacturing

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Batu Kawan; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical device company in Malaysia is seeking a Quality Manager to develop and lead a high-performance quality engineering team. The individual must have a minimum of 10 years managerial experience in the medical industry, with expertise in ISO 13485 and 21 CFR 820 standards. Responsibilities include ensuring compliance, making critical quality decisions, and contributing to a continuous improvement work environment. The role also requires strong leadership and communication skills to motivate the team and drive best practices.

Qualifications

• Minimum 10 years of experience in a managerial capacity within a production environment in the medical industry.
• Well versed in ISO 13485 and 21 CFR 820 requirements.
• Minimum 3 years of experience managing engineers and technicians.

Responsibilities

• Develop and manage a high-performance quality engineering team focused on customer needs and compliance.
• Make decisions related to product quality, including non-conforming product disposition.
• Develop and execute plans for complex projects from a quality perspective.

Skills

Statistics

Understanding of Finance 101

Education

Minimum Degree in Biomedical Science or Engineering

Job description

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 complies with all the regulations governing the quality systems. Ensures their 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 Responsibilities:

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.

Requirement:

Minimum Degree in Biomedical Science, Science or equivalent Engineering field.

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.

Required skills:

Statistics, understanding of Finance 101 will be added advantage.

Unlock job insights

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• How would you rate your English language skills?
• How much notice are you required to give your current employer?
• How many years' experience do you have as a Quality Manager?
• Do you have a Bachelor Degree?