Quality Engineer

ROM TECHNOLOGIES INC•Brookfield, CT

7d•Onsite

About The Position

The Quality Engineer position reports directly to the Director of Quality. The Quality supports the execution of the design and development for new products and supports sustaining activities for existing legacy products.

Requirements

Minimum Experience: 8+ years of experience in Medical Device Industry
B.S. degree in Engineering, Math, Physical Science, or equivalent field
Strong knowledge of 21 CFR Part 820 (CGMP)
Strong knowledge of quality management systems and manufacturing processes
Strong experience with risk management (ISO 14971)
Experience with Design Verification & Validation preferred
Formal GMP and CFR training strongly preferred

Nice To Haves

Multi-tasking, prioritization
Technical writing ability at a level sufficient to complete Design History File documentation (test protocols, test reports).
Strong aptitude with spreadsheet utilization (pivot tables, data analysis and reporting)
Problem-solving, assertiveness
Ability to thrive in a fast-paced environment
Excellent interpersonal and communication skills

Responsibilities

Design and review project documentation, ensuring alignment with defined user needs, intended use, and indications for use, participating in product risk assessments, and working closely with Development to develop appropriate risk-based verification and validation testing requirements.
Support evaluation of complaints and adverse events for MDR (Medical Device Reporting) requirements, ensuring timely escalation and regulatory compliance.
Review nonconforming material (NCRs) for design impact and ensure proper linkage to design changes, risk, and CAPA, and support alignment of DMR/DHR to ensure consistency between design and fielded devices.
Ensure traceability of devices and configurations.
Communicate regularly with Manufacturing and Test counterparts, and proactively engage in issue resolution across design, manufacturing, and field operations, ensuring alignment between designed, built, and fielded product configurations.
Ability to participate in gathering of QA Engineering metrics gathering and compiling for higher level review, including design quality, field performance, and reliability metrics.
Support analysis of product reliability and performance, including failure trends, repair data, and time-to-failure, and collaborate with engineering to drive design improvements.
Audit, monitor, and witness test processes for compliance with requirements and keeping a watchful eye for risk opportunities, ensuring test coverage is complete and reflects intended use and real-world conditions.
Participate in and maintain risk management activities, ensuring risks are identified, updated, and controlled based on design changes, testing results, and post-market data.
Ensure all design changes, upgrades, and component substitutions are evaluated through formal design control processes, including impact assessment, verification/validation, and approval, and prevent uncontrolled changes during manufacturing or refurbishment activities.
Support and ensure software and hardware design control, including requirements traceability, configuration management, and alignment between design outputs and released product configurations.
Work with the Design, Development Engineering, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs, and field feedback including refurbishment data, complaints, and performance trends.