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Equipment & Software Quality Engineer Job Details | Boston Scientific
2 weeks ago
Equipment & Software Quality Engineer
Work mode: Onsite
Onsite Location(s): Penang, MY
Support and maintain the validation system in regards to software validation.
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 advise system owners about validation requirements.
- Analyze areas for improvement and recommend/advice about software solutions.
- Maintain procedures related to Software Validation.
- Minimum 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.
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 youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen.
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