Software Quality Engineer I at Boston Scientific Corporation Malaysia

, , -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Software Validation, Equipment Qualification, Regulatory Compliance, Data Visualization, Change Control, Interdisciplinary Collaboration, Validation Activities, Remediation Efforts, Procedure Maintenance, Audit Support

Industry

Medical Equipment Manufacturing

Description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace. Hybrid Roles: Boston Scientific's hybrid workplace includes Working from Home and onsite. You will have the opportunity to discuss details in the interview. About the Role: Join our dynamic team as a Quality Engineer focused on Equipment Qualification and Software Validation ensuring compliance with BSC requirements for equipment qualification and system validations. You'll work on key processes such as validated reports, spreadsheets, and systems within the Non-Device Software and Equipment Controls sub-process. In this role, you'll collaborate with engineering teams, guiding them through regulatory compliance and ensuring requirements are met during implementation. This is a great opportunity to develop your expertise in quality assurance, work with multidisciplinary teams, and contribute to projects that make a real impact. Key Responsabilites: Provide guidance in equipment classification and qualification activities as needed (Equipment used as part of manufacturing process and supporting areas). Support change control processes related to qualified equipment and validated software. Collaborate with interdisciplinary teams to address alignment activities regarding qualified equipment and validated software requirements. Identify systems requiring validation and provide guide to system owners about validation requirements. Assist in validation activities, including determining which systems require validation and supporting the validation process. Identify and support remediation efforts for installed software, including managing change control processes. Analyze areas for improvement and recommend effective solutions. Assist the Subject Matter Expert in maintaining and updating procedures related to Software Validation and Equipment Qualification. Provide support during internal and external audits. Minimum Requirements: Bachelor's degree in engineering or related field. 85% English Level Preferred qualifications: Experience with Power BI for data visualization and reporting. CRTA #CTGTA #ELCR As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! Benefits * Life-Work Integration * Community * Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.

Responsibilities

The Quality Engineer will focus on Equipment Qualification and Software Validation, ensuring compliance with BSC requirements. This role involves collaborating with engineering teams to guide them through regulatory compliance and support validation processes.