Equipment Software Quality Engineer II

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. 4.2 View all jobs

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.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

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