Equipment Software Quality Engineer II

Location: Penang, Malaysia | N/A

Department: Engineering

Work Location: onsite

Key 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.

Requirements

• Minimum Bachelor’s Degree in Engineering discipline or related field of study or related technical field.
• ASQ Certified Software Quality Engineering Certification (CSQE) or related professional certifications are valued.
• 3-4 years' experience in Quality, QA or related medical device experience.
• Working knowledge of Medical Device Quality Management System.
• Knowledgeable in Quality System Regulations, Medical Device Regulations, ISO 13485 Quality Standards, FDA 21 CFR Part 820 and FDA 21 CFR Part 11.

Required Skills

• Serves as Software QA representative for Software Control Projects, NPI as well as sustaining efforts.
• Support other Software Quality related processes such as non-device software related NCEP/CAPA and risk management.
• Work with cross-functional teams to resolve quality issues related to software.
• Software QA experience within a regulated environment.
• Strong attention to detail with the ability to think critically.
• Ability to work proactively and independently.
• Ability to manage multiple priorities and work efficiently in a fast-paced environment.
• Knowledge of software validation lifecycle, change control, and computerized system validation.
• Strong documentation, problem-solving, and communication skills.
• Experience with Equipment Software Qualification and Validation activities.
• Qualification protocol review and approval experience.
• Stakeholder management and cross-functional collaboration skills.

About Us

As a global medical technology leader for more than 45 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.