Sr. Software Quality Engineer - Medical Device

Looking for a full-time Senior Software Quality Assurance Engineer position to join my team at Austin location. This is a hybrid role.

Key Duties and Responsibilities:

• On New Product Development, leads key Software and Hardware Design Assurance activities to ensure an efficient pre-production quality assurance program for design & development.
• Acts as a Subject Matter Expert for Medical Device Quality Management System regulations and standards, including ISO 13485 and 21 CFR 820, with a focus on 21 CFR 820.30 Design Controls, IEC 62304 Medical Device Software Development and IEC 60601-1.
• Experience in establishing and maintaining a Quality Management System for Medical Device Software solutions, including the creation and maintenance of procedures, work instructions and templates to enable global product launches.
• Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Ensure documentation accuracy, clarity, consistency, completeness, and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports.
• Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.
• Serves as an expert for software and hardware lifecycle Risk Management demonstrating a thorough knowledge and understanding of EN ISO 14971 and IEC 62366. Must be able to lead and perform risk management activities for software and hardware products and contribute to the continuous improvement of the Risk Management Policy and procedures.
• Contributes as a subject expert in Software and Hardware Design Controls and Development Lifecycle Phases. Is experienced in following both agile and waterfall methodologies and actively supports and advises the development teams throughout the lifecycle management of the product.
• Actively participates in and facilitates the development, review and approval of requirements and deliverables required to support product software and/or hardware development (planning, requirements, architecture, verification/validation etc.) including maintenance, configuration management and problem resolution.
• Supports Software Development Lifecycle activities by providing guidance and direction to change originators assembling documents such as Change Control Records.
• Provides clear direction on all quality activities necessary for the business to develop and maintain new software and hardware products. Specifically, deliverables related to product safety, usability, risk management, compliance, and product performance.
• Demonstrates flexibility, open-mindedness, and adaptability to changing environments. Uses technical skills and experience to reach clear and logical decisions.
• Participates in inspections by regulatory bodies, such as FDA and International Notified Bodies acting as an SME for Software and Hardware Design Assurance.
• Performing risk assessments to evaluate potential cyber security threats and their impact on the system.
• Staying updated on emerging cyber security trends and technologies to enhance testing strategies.
• Participates in Corrective and Preventive actions relating to Software and Hardware Development and Risk Management arising from internal audits, external audits and product failure investigations. Supports the local CAPA Review board.

Collaborates with both internal project teams, third party software developers and third party electrical/mechanical engineers (ME/EE), ensuring compliance to regulations, practices and policies. Interprets regulations and maintains an awareness of industry trends on compliance issues. Implements measures to anticipate and avoid regulatory violations.

Qualifications

· Bachelors degree in a scientific, technical, or engineering discipline.

· Minimum 5 years of experience in Software Quality Assurance.

· Knowledge of FDA QSR, ISO guidelines and 21 CFR Part 11.

· knowledge of Design Control requirements and software development lifecycle

· Must have 3 - 5 years project experience in software testing practices, methodologies and techniques, preferably in testing Medical Devices.

· Must have excellent oral and written communication skills.

· Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools

· CQE/CQM preferred

· Experience with Orthopedics Medical Devices preferred.

Cyber Security QA experience preferred

Job Type: Full-time

Pay: $84,924.76 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Compensation package:

• Bonus opportunities
• Profit sharing

Experience:

• IEC 62304: 3 years (Preferred)
• Design controls: 5 years (Preferred)
• 21 CFR Part 820: 5 years (Preferred)

Ability to Relocate:

• Austin, TX 78744: Relocate before starting work (Required)

Work Location: In person