Sr. Software Quality Assurance Engineer

Skills

• Behaviors
• Advanced Software Quality Expertise
• Software Quality systems
• Design controls
• Compliance oversight
• Risk-based decision making
• Provides independent, objective Quality oversight for complex software activities.
• Applies established Quality frameworks with sound judgment.
• Coaches colleagues and leads cross-functional technical reviews.
• Escalates systemic, novel, or significant risks appropriately.
• Technical Expertise
• Software development
• Code review, as needed
• Architecture evaluation, as needed
• Validation methodologies
• Applies technical expertise to assess software Quality and engineering deliverables
• Risk Management
• Software risk assessment
• FMEA
• Cybersecurity risk evaluation
• Makes sound, risk-based decisions
• Proactively identifies potential issues
• Communication & Influence
• Technical writing
• Presentation
• Stakeholder engagement
• Builds strong cross-functional relationships
• Influences without direct authority
• Analytical Thinking
• Root cause analysis
• Problem solving
• Data evaluation
• Investigates issues thoroughly
• Develops practical solutions
• Continuous Improvement
• Process improvement
• Audit readiness
• Quality metrics
• Drives enhancements to systems, processes, and organizational performance
• Work Environment, Physical Demands and Protective Equipment
• · This is a senior individual-contributor role. The position may provide technical guidance, mentoring, and work direction but does not have direct supervisory responsibility unless separately assigned.
• Primarily office-based environment with regular collaboration across Quality, Engineering, Regulatory Affairs, and Product Management functions.
• Requires extensive computer and software system use.
• May involve participation in audits, inspections, manufacturing observations, design reviews, and supplier assessments.
• Must be able to review technical documentation and quality records for extended periods.
• Requires adherence to company quality, information security, and confidentiality requirements.
• Follows protective equipment procedures for each department.
• Schedule, Travel Responsibility, Special Conditions or Requirements
• · Optimal Work Schedule: 8:00am – 5:00pm
• Schedule can be flexible within the range of 6:30am-6:00pm.
• · Must be able to work effectively in a fast-paced, highly regulated environment.
• · Occasional travel may be required to support audits, supplier evaluations, business meetings, training, or regulatory activities.
• · May participate in critical product support, compliance, or investigation activities as business needs require.
• · Must maintain compliance with applicable quality system, cybersecurity, and regulatory requirements.
• Pay Range: $88,000 to $110,000
• Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
• We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [email protected], and please be sure to include the title and the location of the position for which you are applying.