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Qualcomm Life Software Quality Engineer
Ref No.: 18-20566
Location: San Diego, California
Job Overview:
Define and maintain 2net Engineering processes - Collaborate with the QMS team on updating the overall QCL Product Development Process and the related Engineering deliverables and milestones. - Collaborate with the Engineering leads, product managers and program managers on further defining and updating the engineering processes, including risk management, documentation, reviews and traceability. - Generate or guide the generation of the required engineering procedures and document templates Continuously review the engineering processes and their documentation for accuracy, efficiency and consistency - Drive the integration of the appropriate tools into the overall process Ensure process adherence - For each project/product, work with program management and QMS on scheduling the regulatory milestones as part of the projects timeline. - Assist the engineers with producing or updating the required deliverables. - Ensure that the Engineering tools are validated, including updates for new versions. Represent 2net engineering in various audits, including customer audits, ISO 13485, FDA etc.
Minimum Qualifications:
3+ years experience in driving standard compliance in a high-tech industry, including participation in internal and external audits; Experience with the use of ALM tools in the development of complex, hybrid hardware/software systems Excellent verbal and documentation skills
Preferred Qualifications:
- Medical device industry experience - Knowledge of ISO 13485 standard - Familiarity with FDA standard and guidelines
Required: Bachelor's, Computer Engineering and/or Computer Networks & Systems and/or Computer Science and/or Control Theory & Control Eng and/or Electrical Engineering and/or Electronics & Satellites Eng and/or Industrial & Prod Engineering and/or Information Technology and/or Intl Industrial & Fin Strategy
Keywords: ISO 13485, FDA, Compliance audits, application life cycle management, Quality management systems, Development process. Mgr is willing to consider Jr level candidates with 3 yrs experience also.