Senior Quality Engineer

Boston Scientific Gruppe; Penang; On-site; MYR 100,000 - 120,000; Full time

Job summary

A leading medical technology company in Malaysia is looking for a Quality Engineering Manager to oversee manufacturing quality processes. This role requires a strong background in quality assurance within the medical device industry, excellent people management skills, and a degree in Engineering or Science. The successful candidate will ensure compliance with regulatory standards and lead a high-performance team focused on quality innovations.

Qualifications

• Minimum 9 years of experience in manufacturing / operations Quality.
• Prior experience in the medical device industry is preferred.
• Experience in product transfer will be an added advantage.

Responsibilities

• Ensure all direct reports comply with safety and quality regulations.
• Co-ordinate work activities and ensure adequate resources are available.
• Provide direction to subordinates based on policies.
• Perform performance appraisals for reporting staff.
• Handle customer complaints and investigate root causes.

Skills

Interpersonal skills

Problem solving

Communication skills

Process validation

Direct reports management

Leadership

Education

Degree in Engineering or Science

Job description

Responsibilities

• Ensures all direct reports 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.
• Co‑ordinate the work activities within the various work teams and ensuring that adequate resources are available; to meet customer expectations.
• Maintains and enhances cross‑functional /site team relationships.
• Is an effective people manager resulting in a motivated high‑performance team and is fully motivated to achieve and demonstrate best practices in line with the department and Strategic Quality Planning (SQP) objectives.
• Provides direction and support to subordinates based on general policies and management guidance.
• Responsible for performing performance appraisals, for all reporting staff.
• Co‑ordination of staff holidays and for ensuring sufficient cover is available to support manufacturing during shutdown periods.
• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non‑conforming product.
• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non‑conforming material, assisting in
• identification of primary root causes and understanding corrective and preventive actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Participates in Customer Complaints investigation for areas under their control or Laboratory Out Of Specification (OOS) investigation.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Is viewed as a leader in the areas of QSR and ISO/MDD standards within one’s own group, constantly promoting awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decisions.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
• Is familiar with the internal auditing process.

Requirements

• Minimum Degree in Engineering or Science
• Minimum 9 years of experience in manufacturing / operations Quality. Prior experience in the medical device industry is preferred.
• Required skills: Good interpersonal, problem solving & communication skills. Process validation. Direct reports and people management, leadership.
• Experience in product transfer 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.