Senior Quality System Engineer

Boston Scientific; George Town; On-site; MYR 70,000 - 100,000; Full time

Job summary

A leading medical technology company seeks a Compliance Quality Assurance professional with a strong background in internal auditing and regulatory standards. The ideal candidate will have over 9 years of experience in the medical device industry, ensuring compliance with ISO, FDA regulations, and providing quality assurance support. This role requires collaboration across functions and may involve occasional travel to support business needs.

Qualifications

• Minimum of 9 years experience in a manufacturing environment.
• Experience in the medical device industry, CAPA, and audits.
• Lead Auditor qualification is desirable.

Responsibilities

• Implement and ensure compliance with quality systems and regulatory standards.
• Conduct audits and manage non-compliance issues.
• Educate functional areas and lead CAPA systems.

Skills

Internal auditing techniques

Knowledge of regulations (FDA, ISO, cGMP)

Quality system requirements

Data analysis

Education

Degree holder

Job description

Key Responsibilities

• Implement internal requirements and comply with external laws, regulations, guidances, and standards relevant to Boston Scientific quality systems.
• Possess expertise in internal auditing techniques and familiarity with regulatory requirements such as FDA, ISO, cGMP, and MDR.
• Lead and support site external inspections.
• Plan, coordinate, and conduct scheduled audits to assess compliance with applicable standards and internal requirements, including audit scheduling, investigation, and evaluation of observations and findings.
• Identify potential noncompliance or areas for improvement through internal audits.
• Participate in global conference calls and meetings related to the internal audit process.
• Lead the implementation of assurances, process controls, and CAPA systems to meet or exceed requirements.
• Support the site’s corrective and preventive actions process.
• Maintain the BSC Penang CAPA process and develop/distribute CAPA metrics for management.
• Educate functional areas on quality system requirements.
• Collaborate across functions and business units to standardize quality policies and procedures.
• Support quality disciplines, decisions, and practices as a team member.
• Occasionally travel to support the business or other sites.
• Gather and analyze facility quality metrics for management review.
• Collect and analyze business and quality system data across the company.
• If applicable, provide quality assurance support to the analytical laboratory responsible for testing and batch release of drug products and raw materials, ensuring compliance with cGMP and regulatory standards, and support laboratory investigations.

Requirements

• Degree holder.
• Minimum of 9 years experience in a manufacturing environment.
• Experience in the medical device industry, non-conforming event management, CAPA, management review, and audits.
• Knowledge of ISO13485, EU MDR, FDA regulations; familiarity with cGMP and combination device regulations; Lead Auditor qualification is desirable.

About Us

Boston Scientific is a global medical technology leader for over 40 years, dedicated to transforming lives through innovative solutions that improve patient health. Join us to make a meaningful difference worldwide and locally.