Principle Professional Quality

About the role

The Principal Professional Quality position oversees the Quality Assurance program for the Core Dx Digital Health Solution products. This role includes oversight of design and development quality processes, post-market support, and continuous improvement initiatives. The role ensures that product quality and information security standards meet or exceed internal and external requirements and maintains the standard of excellence established by the Core Dx division.

Responsibilities

• Serve as a quality subject matter expert for digital health solutions, providing guidance on quality, compliance, risk management, and software development best practices.
• Lead quality assurance efforts throughout the product lifecycle, including design reviews, risk assessments, verification and validation activities, change control, and product release.
• Collaborate with engineering, product management, and IT teams to ensure quality and security requirements are effectively integrated into design, development, and maintenance processes.
• Support post-market surveillance and customer feedback analysis to drive product improvements and ensure continued compliance.
• Oversee key quality system processes, including document control, nonconformance and CAPA management, and internal audits related to both product quality and information security.
• Maintain and continuously improve certified quality management system (ISO 9001, ISO 27001, etc.), ensuring alignment to divisional, corporate, and external requirements.
• Provide quality oversight of suppliers, contractors, and service providers to ensure compliance with established quality and information security requirements.
• Support and facilitate external and internal audits, certification assessments, customer audits, and regulatory inspections, ensuring organizational readiness and effective resolution of observations.
• Collaborate with global quality teams and technical teams in United States, Portugal, and Italy to drive harmonization, consistency, and continuous improvement across quality processes.
• May serve as the Management Representative for the Quality System; acts as a point of contact providing quality guidance and expertise for digital products to represent the organization as the main interface with necessary regulatory bodies and external auditors.

Requirements

• Associate’s degree in engineering, quality assurance, or a related technical field.
• Minimum 3+ years of experience in quality assurance or quality control, preferably in product development, regulated environments, non-medical products, or digital health.
• Experience with ISO 9001 and ISO 27001 quality systems preferred.
• Familiarity with agile development, design control, risk management, and post-market surveillance processes.

Preferred Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Quality Engineering, Biomedical Engineering, Information Systems, or a related technical discipline.
• 6+ years of progressive Quality Assurance experience supporting software, digital health, diagnostics, medical devices, or other regulated product environments.
• Demonstrated ability to lead design reviews, risk assessments, root cause investigations, CAPA activities, and supplier quality management.
• Knowledge of software development methodologies, including Agile and Scrum, with familiarity in cybersecurity and information security principles, risk management frameworks, secure software development practices, and information security controls.
• Proven ability to independently manage multiple priorities, lead complex quality initiatives, and deliver results in a fast-paced, global environment with cross-functional teams, including engineering, product management, marketing, regulatory affairs, IT, cybersecurity, and suppliers.
• Strong communication, organizational, and problem-solving skills, with the ability to influence stakeholders and drive continuous improvement.

Pay

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.