Site Quality Leader – Medical Devices

Stevanato Group; Ontario (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Medical benefits

401(k)

Job summary

Stevanato Group is seeking a Quality Manager to lead a comprehensive quality management system, ensuring compliance with ISO 13485, ISO 9000, and FDA 21 CFR 820 across the site. You will manage the quality department, drive CAPA, metrology, and customer complaint processes, and partner with manufacturing to sustain continuous improvement.

The role requires strong leadership, extensive regulatory knowledge, and the ability to read drawings and GD&T, with experience in injection molding a plus.

Qualifications

• Bachelor's degree in science, engineering or related field.
• At least 5 years leading quality systems in pharma/medical device.
• Experience with ISO 13485, ISO 9000, 21 CFR 820 and cGMP.
• Experience with injection molding plastics manufacturing is a plus.
• Ability to read drawings and GD&T.

Responsibilities

• Build and maintain a compliant QMS aligned with ISO 9001/13485 and FDA 21 CFR 820.
• Lead quality systems through process capability, inspection, auditing, and statistics.
• Oversee training and development for the quality department and onboarding of new hires.
• Direct internal and supplier audits and drive corrective actions.
• Ensure shift-to-shift communication and safe working environment.

Skills

Leadership

Regulatory knowledge

Quality systems

Root cause analysis

Metrology

Gage R&R

Statistical methods

Process validation

Documentation control

Communication skills

Six Sigma

Education

Bachelor’s degree in engineering or science

Six Sigma certification

Regulatory training

Tools

PC-DMIS

IQMS

Minitab

Excel

Outlook

Job description

Stevanato Group is seeking a Quality Manager to lead a comprehensive quality management system, ensuring compliance with ISO 13485, ISO 9000, and FDA 21 CFR 820 across the site. You will manage the quality department, drive CAPA, metrology, and customer complaint processes, and partner with manufacturing to sustain continuous improvement.

The role requires strong leadership, extensive regulatory knowledge, and the ability to read drawings and GD&T, with experience in injection molding a plus.