Job Description :
Job Title: Software Quality Engineer (Medical Device)
Duration: 12 months
Location: Santa Clara 95054
Responsibilities:
Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.
General - Defines project goals and milestones.
Responsible for timely project completion.
Provides solutions to a wide range of difficult problems.
Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
May lead projects with cross-functional or broader scope.
Interacts effectively with employees, manager, and cross-functional peers.
May represent own team while on cross-functional project teams with other functional leaders.
Communicates confidently and effectively with management, peers, and key stakeholders.
Implements tactical solutions related to assignment.
Able to contribute functional skills and expertise broadly.
Directly influences project direction and scope.
Scope includes one or more QA functions, with general knowledge of other related disciplines.
Provides guidance and trains other Professionals and Technicians.
May provide oversight to one or more QA professionals and/or contractors.
Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.
Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
Risk Management - Ensures evaluation of product safety and efficacy and elevation of risk-based issues.
Creates and reviews risk management documentation to reduce or eliminate risk.
Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
Authors risk control packages and demonstrates the ability to analyze, evaluate, and control risk decisions by utilizing common practices throughout the quality.
Complaint Evaluation - Investigates complex complaints with little management oversight.
Provides solutions to a wide range of problems.
Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
Ensures compliant documentation in area of responsibility.
Design Control / Documentation & Change Control - Formulates thorough reason and justification for change.
Identifies critical parameters associated with change.
Represents the site as an SME or Process Community member.
Quality Engineering - Applies solid understanding of quality system elements from product inception through launch.
While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various departments including, as needed, external suppliers.
Validation - Acts as Subject Matter Expert (SME) for minimum of at least one respective Validation Subsystem.
Key Skills:
Strong experience in supporting Software Quality activities for Product Software, familiar with IEC 62304 – Medical Device Software – Software Lifecycle Processes
strong knowledge in Design Assurance / Design Controls activities (Design Planning, Verification, Validation, document review, problem-solving, product development team support
Experience using Defect Management tools, Document Control software.
Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred experience in the Healthcare industry. Has a history of completing successful projects and driving positive compliance outcomes.