Sr. Software Quality Assurance Engineer I

Tandem Diabetes Care•California - High Bluff, CA

1d•$109,000 - $130,000•Hybrid

About The Position

Serves as the Software Quality Assurance Engineer supporting software product development programs, ensuring software products are developed, validated, and maintained in compliance with applicable quality system and regulatory requirements. Applies knowledge of software lifecycle development, quality processes, and risk management to review development activities, identify quality and compliance risks, and provide guidance on quality best practices. Supports continuous improvement of quality processes to meet department, business unit, and company objectives and serves as the quality representative on cross-functional product teams.

Requirements

Bachelor's degree in Engineering, Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline
Minimum 5 years of experience in software quality assurance, software quality engineering, or related quality functions within the medical device or other regulated industry.
Experience supporting software development from concept through commercial release.
Experience with Design Controls, risk management, software verification and validation, and software anomaly management.
Knowledge of medical device software development processes, including mobile, embedded, and web-based technologies.
Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, IEC 62304, and other applicable medical device regulations and standards.
Working knowledge of Design Controls, risk management, verification and validation, software anomaly management, and traceability principles.
Familiarity with Good Documentation Practices (GDP).
Ability to effectively use Microsoft Office applications and other business software tools.
Excellent written, verbal, and interpersonal communication skills.
Ability to analyze and interpret technical information and communicate quality and compliance requirements effectively.
Ability to influence cross-functional teams and facilitate resolution of quality and compliance concerns.
Demonstrated ability to work independently and manage multiple priorities.

Nice To Haves

Experience with application lifecycle management and defect tracking tools preferred.
Experience with software development languages and technologies such as JavaScript, C, or similar technologies preferred.

Responsibilities

Serves as a Quality representative on project core teams and provides quality guidance throughout software development activities.
Reviews and approves design control deliverables, including requirements, risk management files, verification and validation documentation, traceability records, software change assessments, and design review outputs for compliance with company procedures and regulatory requirements.
Participates in risk management activities, including identification, evaluation, documentation, and maintenance of product risks, and reviews risk management documentation for compliance with company procedures and applicable standards.
Provides traceability analysis and reporting to ensure requirements, risks, verification, and validation activities are appropriately linked and documented.
Provides quality oversight of software anomaly management activities, including review of issue assessments, defect investigations, risk evaluations, unresolved anomalies, and disposition decisions in accordance with company procedures and regulatory requirements.
Reviews software verification and validation activities and associated test results to ensure requirements are met and documentation is complete and compliant.
Participates in design reviews and evaluates design review evidence for compliance with company procedures and design control requirements.
Supports maintenance of the Design and Development File and other development records to ensure completeness, traceability, and compliance.
Provides quality input to software changes, product releases, and release readiness activities.
Evaluates and recommends quality-related process improvements, tools, and methodologies.
Supports Complaint, Field Investigation (FI), Correction and Corrective Action (CA), and CAPA investigations and executes assigned corrective actions when applicable.
Provides quality support during internal, external, customer, and regulatory audits and inspections.
Ensures work is performed in compliance with company policies, including Privacy/HIPAA requirements, and applicable regulatory, legal, and safety requirements.
Supports other departments as needed and considers project-wide impacts in decision making.
Performs other duties as assigned.