Quality Engineering Technician

Job Title

Quality Engineering Technician

Quality

Quality Manager

In-Person

Salary - $80,000 to $90,000 (Based on Experience)

Full-Time, Monday-Friday, 40 hours/week

Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.

The Quality Engineering Technician leads the Quality activities required for medical device development and manufacturing. This role provides hands‑on experience in quality engineering fundamentals and performs Quality engineering activities such as data collection, statistical analysis, writing technical documentation, and development and execution of test and validation protocols. The position also includes the ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions;

and give oral presentations.

The technician leads independently on core engineering technician practices, contributes to process improvements, and performs Quality activities within design and manufacturing controls for a regulated environment. The position shall author engineering protocols and reports, work on multiple tasks and projects with effectiveness and efficiency, and participate in quality operations and production activities as needed.

• Independently author, review and approve complex quality protocols, validation plans and reports.
• Lead verification, validation and method development initiatives; define test strategies, establish acceptance criteria, and interpret complex data.
• Lead cross‑functional teams to develop, optimize and implement quality SOPs and manufacturing/test instructions.
• Design, execute and statistically analyze advanced measurement system analyses (e.g., Gage R&R, capability studies, DOE).
• Work from drawings, solid models, written and verbal descriptions or defined plans to perform testing and troubleshoot functions.
• Apply advanced statistical tools (ANOVA, regression, SPC) to identify process trends and drive continuous improvement initiatives.
• Develop and maintain data reporting systems and dashboards; translate data into actionable insights for product and process optimization.
• Lead root cause analyses and CAPA activities, developing corrective/preventive strategies.
• Ensure quality system documentation and record‑keeping activities comply with established procedures and work instructions.
• Proactively identify opportunities for process and product improvement, driving initiatives to enhance operational excellence and compliance.
• Demonstrate safe work practices and maintain a clean, organized work area.
• Perform other duties as assigned by the manager.

• Associates or Technical degree with a minimum of 10+ years of progressively responsible experience in the medical device industry under ISO 13485 and related regulatory standards (FDA, QSR, EU MDR).
• Demonstrated understanding of quality system principles, risk management and validation practices within regulated environments.
• Advanced math and analytical aptitude, with proven ability to apply statistical tools to support process capability, Gage R&R, and data‑driven decision making.
• Proficient with digital tools and technical software, including Microsoft Office applications, Minitab, and Visio.
• Exceptional technical communication skills – able to author, review and approve quality protocols and technical summaries that meet internal and regulatory documentation standards.
• Experience providing cross‑functional support to design, manufacturing, and quality engineering teams, including leading verification/validation activities, troubleshooting, and root cause analyses.
• Strong background in electronics manufacturing, with a comprehensive understanding of electrical and mechanical testing methods and instrumentation.
• Demonstrated ability to mentor junior…