Senior Quality System Engineer

Boston Scientific; Penang; On-site; MYR 284,784 - 366,151; Full time

Job summary

Boston Scientific in Penang, Malaysia, is looking for a qualified professional to ensure compliance with quality systems and regulatory requirements. This role involves leading audits, supporting CAPA processes, and driving continuous improvement initiatives.

Applicants should possess a Bachelor’s Degree and a minimum of 9 years of experience, ideally in the medical device industry. Knowledge of ISO 13485 and FDA regulations is essential.

Qualifications

• Minimum 9 years of experience in a manufacturing environment.
• Experience in the medical device industry is desirable.

Responsibilities

• Ensure compliance with internal quality systems and external regulatory requirements.
• Lead and support external inspections and regulatory audits.
• Plan, coordinate, and conduct internal audits.
• Identify areas of non-compliance and drive continuous improvement initiatives.
• Act as subject matter expert (SME) for CAPA processes.

Skills

Knowledge of ISO 13485

Knowledge of FDA regulations

Non-conformance management

CAPA management

Lead Auditor certification

Education

Bachelor’s Degree in Science, Engineering, or related field

Job description

Key Responsibilities:

• Ensure compliance with internal quality systems and external regulatory requirements (e.g., FDA, ISO 13485, cGMP, EU MDR and other applicable standards)
• Lead and support external inspections and regulatory audits
• Plan, coordinate, and conduct internal audits, including identifying gaps, investigating findings, and driving corrective actions
• Identify areas of non-compliance and drive continuous improvement initiatives
• Act as subject matter expert (SME) for CAPA processes, ensuring effective implementation and timely closure
• Maintain and continuously improve site CAPA processes and systems
• Develop, track, and report CAPA metrics to support management review activities
• Support corrective and preventive action processes across the site
• Collaborate cross-functionally to standardize quality system policies and procedures
• Provide training and guidance to teams on quality system requirements
• Gather and analyze quality system data to support management review and decision making
• Participate in global quality system initiatives and discussions
• Provide quality oversight to analytical laboratory activities, including compliance with cGMP and support for investigations (e.g., OOS/OOT), where applicable

Requirements:

• Bachelor’s Degree in Science, Engineering, or a related field
• Minimum 9 years of experience in a manufacturing environment
• Experience in the medical device industry is desirable
• Experience in: Non-conformance and CAPA management, Management Review processes, Internal and external audits

Required Skills & Knowledge:

• Knowledge of ISO 13485, EU MDR, and FDA regulations
• Knowledge of cGMP and combination product/device regulations
• Lead Auditor certification is an added advantage