Principal Software Design Quality Engineer

South Bay, CA

Posted: 08/24/2018 Employment Type: Direct Hire Industry: Healthcare Job Number: JOS000007882

Essential Job Functions

• Work closely with Regulatory, R&D, Test and Manufacturing, to ensure the highest quality products and processes are being developed and deployed.
• Create Software Quality Assurance (SQA) strategy and operational execution plans.
• Offer technical expertise in the testing area within the organization
• Knowledge of and experience in developing and medical devices in conformance with Quality System Regulations, ISO13485 and 14971 requirements.
• Applies knowledge of IEC 62304 and IEC 60601 to product development and sustaining engineering projects.
• Engage with the developer community to align best practices and techniques for automated unit and integration testing.
• Report defects found through defect tracking system, provide necessary information to reproduce the defect to arrive at a solution.
• Serve as primary quality representative on one or more teams.
• Lead / Contribute to all elements of risk management. Assesses software risk by facilitating the development of risk management tools such as Fault tree analysis, failure mode and effects analysis (FMEAs) and contribute to the completion of the overall product risk management file.
• Support Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities. Develop and execute system related verification and validation plans and protocols, and write test reports.
• Identify product quality and quality system improvement opportunities and drive procedure updates when required.
• Supports new product launches to ensure suppliers are capable of delivering to the required quality standards
• Support departmental effort in CAPA investigation and completion.
• Collect, analyze, trend, and communicate quality data throughout the organization.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
• Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance Excellent interpersonal skills
• A self-starter, motivated and able to positively motivate others
• Focused, target driven with a positive, can-do attitude

Requirements/Qualifications -
Bachelor’s degree in Computer Science, Electrical or Software Engineering (or similar). Master’s degree preferred. -
Minimum of 10 years of hands on experience with Design Assurance / Quality Engineering. -
Prior experiences in the medical device field is required, preferably experience with Capital Equipment medical devices. -
Previous experience supporting external audits (example: Notified Body or FDA) -
Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements,
Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. -
Ability to work effectively in a fast paced and dynamic environment. -
Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers; strong written and verbal communication skills.

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