Quality Engineer - ISO 13485 | CAPA & Process Improvement

SaniSure; Twinsburg (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

SaniSure is seeking a Quality Engineer to ensure Twinsburg, OH manufactured products meet regulatory and internal QMS standards. You will work with Operations, Manufacturing Engineering, Maintenance, and Quality teams to support manufacturing, batch release, investigations, and continuous improvement initiatives.

Ideal candidates have 3–6 years in quality engineering within medical devices or biotech, strong statistical and documentation skills, and the ability to drive cross-functional

Qualifications

• 3–6 years of Quality Engineering experience in medical device/pharma/biotech industries.
• Solid knowledge of ISO 13485 QMS and product release activities.
• Experience with CAPA, nonconformance, change control, and documentation control.

Responsibilities

• Support investigations, CAPA, and nonconformances across design and manufacturing.
• Assist with audits and corrective actions from findings.
• Drive continuous improvement of extrusion processes and quality metrics.
• Maintain documentation and SOPs; participate in change controls and product releases.
• Analyze data for process improvements and risk reduction.

Skills

Quality engineering

ISO 13485

CAPA

Nonconformance

Statistical analysis

Root cause analysis

Cross-functional teamwork

Technical writing

MS Office

Education

Bachelor's degree in Science/Engineering or related field

Tools

MS Office

Job description

SaniSure is seeking a Quality Engineer to ensure Twinsburg, OH manufactured products meet regulatory and internal QMS standards. You will work with Operations, Manufacturing Engineering, Maintenance, and Quality teams to support manufacturing, batch release, investigations, and continuous improvement initiatives.

Ideal candidates have 3–6 years in quality engineering within medical devices or biotech, strong statistical and documentation skills, and the ability to drive cross-functional