Product Quality Assurance Specialist

The Product Quality Assurance Specialist ensures our medical device software consistently meets stringent quality, regulatory, and customer standards. This role involves developing detailed product specifications, conducting risk assessments, creating and executing verification and validation (V&V) plans, and ensuring successful software releases. Collaborating closely with development teams, the Product QA Specialist analyzes test results, resolves product issues, and authors technical documentation. This position is critical in safeguarding the company's reputation by identifying quality deviations and ensuring compliance with internal policies and external regulatory standards.

Key Responsibilities:

Verification & Validation Testing

• Develop, implement, and maintain test protocols and test cases to support formal verification and validation of medical device software in compliance with regulatory standards.
• Execute V&V test cases to verify functional requirements and validate that software meets requirements, with an emphasis on performance, reliability, and risk mitigation for new releases.
• Actively participate in daily development activities, coordinating verification and validation efforts to maintain alignment between quality and development teams.
• Collaborate with the development team in planning sprint scopes and managing testing timelines.

Defect & Complaint Management

• Investigate customer complaints and non-conformances, and drive root cause analysis to recommend and monitor corrective and preventive actions (CAPAs).
• Maintain comprehensive documentation of investigations, resolutions, and associated quality records in compliance with regulatory and internal quality system requirements.
• Customer defects review and prioritization process.

QA & Technical Documentation

• Draft and update software specifications.
• Participate in internal audits and quality assurance activities assessing the adequacy of existing quality standards.
• Assist in collecting and compiling statistical quality data to identify areas for improvement in the quality system.

Education and Experience

A bachelor's degree in computer science, engineering, or a related field—or equivalent experience—that qualifies you to perform the essential functions of the role.

Professional Experience:

• Experience as a Software Quality Assurance Specialist or in a similar role.
• Hands-on experience managing software verification and validation (V&V) activities for product release.
• Strong knowledge of software development lifecycle (SDLC), QA methodologies, and quality standards.
• Desirable to have skill in statistical data analysis, test automation frameworks, and version control systems.

Technical Skills:

• Proficient with MS Office.
• Understanding of programming concepts and basic scripting; experience with PHP/MySQL is an asset.
• Familiarity with regulatory compliance standards, especially in medical device software (such as ISO 14385, IEC 62304, FDA 21 CFR Part 820 guidelines, or MDR).

Organizational and Communication Skills:

• Excellent organizational skills and attention to detail.
• Strong written and verbal communication skills.
• Ability to work within a controlled, regulated environment and manage confidential information appropriately.

Physical Requirements and Working Conditions:

Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer, stamina to maintain attention to detail despite interruptions, strength to lift and carry objects weighing up to 40 pounds; vision to read printed materials on a computer screen; and hearing and speech to communicate in person and over the telephone.

Core Sound Imaging is an equal opportunity employer and specifies that employment decisions are based on merit and qualifications, not on factors like race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by federal, state, or local laws.