Equipment & Software Quality Engineer
Boston ScientificGeorge Town, Penang, Malaysia30+ days ago
Job descriptionMinimum Degree in Computer Science / Computer Engineering / Electrical Engineering or related technical field. Education / experience in software development is preferred. ASQ Certified Software Quality Engineering Certification (CSQE) or any professional certifications are valued. 3 - 5 years working experience in Software Quality Assurance within the Medical Device Industry. Possesses knowledge of pertinent regulations and standard regulatory requirements (e.g. ISO 13485, 21 CFR Part 820, 21 CFR Part 11, etc.) and medical device Quality Management System. Serves as the Quality representative for Software Control Projects, NPI as well as sustaining efforts. Able to support software development / validation initiatives by identifying software-related quality issues and ensuring compliance. Able to collaborate effectively with cross-functional team.
Support and maintain the validation system in regards to software validation.
Purpose Statement
Job 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.
Job Requirement
About Us
As a global medical technology leader for more than 40 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 is an Equal Opportunity Employer.
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Quality Engineer • George Town, Penang, Malaysia
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