Quality Engineer (Medical Devices & Injection Molding)

Rayzan InfoTech LLC; Watertown (CT); On-site; USD 95,000 - 125,000; Full time

Job summary

Rayzan InfoTech LLC is seeking a Senior Quality Engineer to drive metrology programs, control plans, and data‑driven quality improvements across Engineering, Manufacturing, and QA teams in Connecticut. The role emphasizes robust measurement, nonconformity resolution, and prevention of process variation.

The ideal candidate has 7–10 years in QE, strong root cause analysis skills, GD&T proficiency, and hands‑on experience with Minitab and measurement tooling in a regulated environment.

Qualifications

• 7–10 years of quality engineering experience in a regulated manufacturing environment.
• Structured root cause analysis and problem solving.
• Proficient in statistical analysis and Minitab.
• Strong GD&T interpretation and familiarity with injection molding is a plus.

Responsibilities

• Develop measurement programs and templates to support QC inspectors and metrologists.
• Lead root cause analysis and sustained corrective actions across departments.
• Coach QC staff on measurement techniques and best practices.
• Design and implement control plans for new products during development and launch.
• Ensure compliance with internal standards and customer requirements throughout the product lifecycle.

Skills

Root cause analysis

Structured problem solving

Statistical analysis

Minitab

SPC

GD&T

SolidWorks

Metrology

CMMs

Data analysis

Education

ASME/BSME or related degree

Lean Six Sigma Black Belt

CQE

ISO 13485 knowledge

Tools

Keyence

CT Scanner

OGP

Job description

Complete quality engineering initiatives to support Engineering, Manufacturing, and all other departments to improve measurement, detection, and prevention of quality issues.

• Use structured problem‑solving methodologies across departments to analyze and provide root cause analysis.
• Help drive continuous improvement initiatives to minimize process variation, scrap, and Cost of Poor Quality (COPQ) through proactive analysis and lean principles.

RESPONSIBILITIES / AUTHORITY

Serve as a key technical liaison with customers to address quality concerns, manage complaint resolution, and ensure timely, data‑driven responses to issues affecting product performance or compliance.

• Use structured problem‑solving techniques to converge on root cause
• Ensure changes put in place are effective at long term prevention
• Measure effectiveness
• Teach techniques and staff to eliminate problems

Provide analysis, support, and lead measurement efforts and establishment of control plans and methodologies for new products during development and launch process working with Engineering program managers.

• Create measurement programs, Keyence, CT Scanner, OGP
• Create templates in ERP for inspection
• Design process to be used by floor inspectors, operators, QA techs
• Design gauges when necessary
• Research and recommend next generation of measurement methods, technology, and automation; to improve accuracy and consistency and increase the number of parts we can analyze for both metrology and production departments.
• Evaluate product and process changes, recommend quality improvements, and enforce adherence to internal standards and customer requirements throughout the product lifecycle.

DUTIES

• Develop a strong working knowledge of precision measurement equipment (e.g., CMMs, vision systems, etc.) to measure parts, write programs, provide technical guidance, support troubleshooting, and provide hands on training for QC Inspectors and metrologists in proper operation, programming and best practices.
• Provide all QC inspection personnel (dimensional and visual inspections) with clarification to questions on parts and equipment.
• Direct, design and develop custom mechanical or electromechanical fixtures, gauges, and tools to streamline inspection processes and enable effective use by QC technicians and/or shop floor operators.
• Direct effective implementation and long‑term sustainability of root cause corrective actions and continuous improvement initiatives, in alignment with the company’s and departments, and customer quality requirements.
• Procure or assist in the selection, specification, ordering, and implementation of quality‑related equipment, inspection systems, and facility improvements that support enhanced product quality, process control, automation, productivity, and regulatory compliance.
• Measure and inspect parts when needed to support Engineering, Metrology, or Quality groups and the company.

EDUCATION

• ASME, BSME, or other technical degree preferred.
• Alternatively, a degree in a closely related technical discipline that emphasizes analytical thinking, design principles, and structured problem solving.
• Lean/Six Sigma Black Belt certification, CQE, a plus.

EXPERIENCE

• 7-10 years of industry experience with a minimum of 3-5 years of QE experience.
• Structured root cause analysis and problem solving, ideally within the medical device components industry or a similarly regulated manufacturing environment. Experience with ISO 13485:2016 a plus.
• Proficient in statistical analysis tools and techniques; experience with Minitab, SPC methods.
• Strong experience in interpreting engineering drawings and specifications, with proficiency in GD&T; familiarity with injection molding processes is a plus.
• Proficient in SolidWorks, with demonstrated ability to design fixtures, inspection tooling, and quality‑related mechanical components;
• Proficiency in Microsoft Excel for data analysis, reporting, and visualization; working knowledge of other Microsoft Office tools including Word, PowerPoint, and MS Project.