Equipment Software QA Engineer II – Validation & Compliance

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 60,000 - 90,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. is seeking a Software Quality Assurance professional to support validation activities and ensure compliance with regulatory standards in a fast-paced medical device environment.

The role requires a engineering degree, 3–4 years of QA experience in the medical device sector, and strong attention to detail. You will collaborate with cross-functional teams to maintain QMS processes and drive quality improvements in software validation.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• ASQ CSQE or related certifications valued.
• 3–4 years' experience in Quality, QA or related medical device experience.
• Working knowledge of Medical Device Quality Management System.
• Familiar with ISO 13485, FDA 21 CFR Part 820 and Part 11.

Responsibilities

• Provide support to the validation department in regards to decisions on what systems require validation as well as support the validation/remediation of software installed in the company, maintain the change control of the software and provide guidance in IQ creation and execution.
• Identify areas that may require software validation and advice system owners about validation requirements.
• Analyze areas for improvement and recommend/advice about software solutions.
• Maintain procedures related to Software Validation.
• Support project transfer teams on Equipment Software Qualification and other non-device software validation activities to ensure compliance requirements are met.
• Participate in Equipment Qualification Strategy and Planning meetings.
• Support qualification deliverables review and approval activities.Partner with cross-functional stakeholders to ensure successful software validation and compliance execution.
• Support software-related quality processes including change control, risk management, NCEP, and CAPA activities.

Skills

Software QA

Quality Assurance

Cross-functional collaboration

Documentation

Attention to detail

Education

Bachelor's degree in Engineering

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. is seeking a Software Quality Assurance professional to support validation activities and ensure compliance with regulatory standards in a fast-paced medical device environment.

The role requires a engineering degree, 3–4 years of QA experience in the medical device sector, and strong attention to detail. You will collaborate with cross-functional teams to maintain QMS processes and drive quality improvements in software validation.