Apply on Employer Site

Connecticut Innovations · 20 hours ago

Senior Quality Engineer

NYC Metro Area

Full-time

Onsite

Senior Level

5+ years exp

Connecticut Innovations is Connecticut’s strategic venture capital arm, passionate about serving its portfolio of over 220 companies. Perosphere Technologies is seeking a Senior Quality Engineer to lead quality management and compliance efforts for their in-vitro diagnostic medical device, working closely with cross-functional teams to ensure regulatory standards are met throughout the product lifecycle.

BiotechnologyEnergyInformation TechnologyMedia and Entertainment

H1B Sponsor Likely

Hiring Manager

Marina D.

Responsibilities

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

Qualification

ISO 13485FDA 21 CFR 820Quality Management SystemRisk ManagementSoftware Development LifecycleTechnical DocumentationAgile/ScrumConfiguration ManagementCollaboration SkillsWritten Communication

Required

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

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

Excellent written communication, organization, and collaboration skills

Ability to interpret and apply regulatory requirements in a practical development setting

Preferred

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

Company

Connecticut Innovations

Connecticut Innovations provides strategic capital and operational insight to to companies in high-tech industries

Founded in 1995

Rocky Hill, Connecticut, USA

11-50 employees

http://www.ctinnovations.com

H1B Sponsorship

Connecticut Innovations has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2021 (1)

2020 (1)