Senior Quality Engineer

Are you ready to join Connecticut Innovation’s vibrant community of innovators? Connecticut Innovations (“CI”) is Connecticut’s strategic venture capital arm, and we are passionate about serving our portfolio of 220 companies across various industries, with strengths in life sciences, technology, and climate tech.

Come join one of our quickly growing portfolio companies, Home - Perosphere Technologies!

Perosphere Technologies is hiring a Senior Quality Engineer to join the team based in Danbury, CT! This will be an onsite role, 5 days a week.

About Perosphere Technologies

Perosphere is an emerging medical device company which designs, develops and manufactures a diagnostic medical device with addresses an unmet need in a critical medical market. The company’s technology provides an innovative approach to management of critical medical conditions related to hemostasis, i.e., blood coagulation and therapeutic anticoagulation. The Senior Quality Engineeer will play a central and key role in the company’s global market penetration by leading ambitious programs for both company and device certifications and registrations in the USA and on a global basis. The incumbent is a key member of middle management and works side-by-side with the Executive Leadership Team to plan, execute and deliver on these strategic objectives.

Senior Quality Engineer

The Senior (Sr) Quality Engineer to support the development, production and post-market activities associated with the company’s in-vitro diagnostic medical device product including hardware, software, and the disposable cuvette device. Such activities relate to operations, manufacturing, technical and product support and related and compliance. The (Sr) QE will serve as the quality representative in Product Lifecyle Management (PLM) which is responsible for products and devices from design through production and post market activities. The (Sr) QE will operate as the quality representative on all design teams, quality process improvements and compliance related systems and remediation as required related to complaints, nonconformance and corrective and preventative action (CAPA), calibration, performance indicators and internal and external auditing and supplier related documents that support the company's products.

What You'll Do:

• The (Sr) QE works within the Quality Management System (QMS) to ensure all activities are properly documented and recorded.
• Partner with software and biomedical development teams to ensure quality and regulatory requirements are built into every phase of the product lifecycle management (PLM), software development lifecycle (SDLC) and medical device development lifecycle.
• Review and approve test plans, validation protocols and reports, and other design history file documentation ensuring alignment with regulatory requirements.
• Author, approve, and implement quality procedures, instructions and records related to design control, risk management, product development, and software development.
• Define, implement, and maintain standard operating procedures (SOPs), work instructions, templates, and quality records related to medical device and software design, development, and testing.
• Facilitate thorough investigations, develop effective action plans, and lead closure of customer complaints, nonconformances (NCs) and CAPA (Corrective Action and Preventive Action).
• Lead the creation and maintenance of key deliverables such as:

Compliance related activities of the QMS related to development

Design History Files (DHF)

Software Requirements Specifications (SRS)

Product Performance Studies and Documentation of results

Risk Management Files (per ISO 14971)

Verification & Validation (V&V) protocol and report documentation

Traceability matrices (requirements → testing)

• Software development documentation in compliance with IEC 62304.
• Ensure compliance with applicable regulatory standards, including ISO 13485, ISO 14971, (EU) 2017/746 (IVDR), and FDA 21 CFR 820. • Lead efforts with cross-functional teams (RA/QA, Operations, Engineering, Research and Development) to audit and improve medical device and software development processes.
• Support internal and external audits and lead remediation actions where needed.
• Drive continuous improvement initiatives by identifying process inefficiencies and implementing solutions.
• Lead efforts with Research and Development, Operations and leadership to drive quality culture and regulatory compliance across organization and suppliers.
• Lead supplier approval, evaluation, and quality improvement initiatives.

Education and Experience:

• Bachelor’s Degree in Engineering, Computer Science, Life Sciences, or a related field.
• 5 - 7 years of experience in Quality System related Engineering including experience with medical device software development, ideally within the diagnostics industry.

Knowledge Skills & Abilities:

• Working practical knowledge of ISO 13485, ISO 14971, (EU) 2017/746 (IVDR), FDA 21 CFR 820 and related regulatory requirements.
• Strong experience with technical documentation, configuration management, change control, and risk management processes.
• Familiarity with software development practices (Agile/Scrum) and tools (e.g., Jira, Confluence, Git). Experience working with electronic quality management systems (eQMS) is a plus.
• Excellent written communication, organization, and collaboration skills.
• Ability to interpret and apply regulatory requirements in a practical development setting

Why Work at Perosphere Technologies?

Purpose-Driven Work: Help shape the standard of care for millions of patients on DOACs.

Market Opportunity: ~$1B addressable market across U.S. and EU hospital systems.

Innovation & Impact: Be at the forefront of hospital-based precision diagnostics.

Perosphere Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.