Senior Software Quality Engineer - Medical DevicesIntellectt Inc • Pleasanton, CA, United States
Senior Software Quality Engineer - Medical Devices
Intellectt Inc • Pleasanton, CA, United States
1 day ago
Job type
- Full-time
Job descriptionBS degree in Engineering or Technical Field or equivalent experience. At least 5 years Quality Engineering experience. Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485. Advanced computer skills, including data analysis and report writing skills. Prior medical device or IVD experience preferred. ASQ CSQE certification desired. Experience working in a broader enterprise / cross-division business unit model preferred.
Role : Senior Software Quality
Location : Pleasanton, CA - 94588
Duration : 12 Months
Shift Timings : 8 AM to 5 PM
Duties :
- Work with Design and Test Engineering in the completion of system / software requirements and other verification and validation processes.
- Review software validation protocols traceable to system / software requirements.
- Participate in meetings and provide guidance on Software Event / Defect or anomalies.
- Responsible for driving the completion and maintenance of risk analysis, focused on software related risks.
- Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing).
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
- Software scoping and Part 11 audits.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Qualifications :
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Quality Engineer • Pleasanton, CA, United States