Senior Quality Systems Engineer - FDA/ISO Compliance

Savaria Corporation; Maryland Heights (MO); On-site; USD 90,000 - 140,000; Full time

Job summary

Savaria Corporation is seeking a Quality Systems Engineer to define, implement and maintain an effective Quality System in accordance with FDA QSR and ISO 13485. The role is 100% on-site at 10888 Metro Ct., Maryland Heights, MO 63043, with responsibilities spanning audits, documentation, CAPA and process control.

The ideal candidate will have a Bachelor’s degree in Engineering/Math/Science and 8–10 years of medical device quality experience, with strong regulatory and leadership skills to drive

Qualifications

• Bachelor’s degree in Engineering/Math/Science with 8–10 years of quality experience in medical devices.
• Experience in FDA and ISO regulatory environments.
• Ability to lead audits and regulatory inspections.
• Strong documentation and corrective action follow-up.

Responsibilities

• Develop, implement and monitor quality metrics for the facility.
• Document quality systems and programs to ensure compliance with FDA/ISO requirements.
• Lead regulatory inspections, ISO audits and customer audits.
• Support internal audit program and address deviations.

Skills

Quality systems

Regulatory compliance

Audits

Documentation

Education

Bachelor’s Degree in Engineering/Math/Science

Tools

MiniTab

MS Office

Job description

Savaria Corporation is seeking a Quality Systems Engineer to define, implement and maintain an effective Quality System in accordance with FDA QSR and ISO 13485. The role is 100% on-site at 10888 Metro Ct., Maryland Heights, MO 63043, with responsibilities spanning audits, documentation, CAPA and process control.

The ideal candidate will have a Bachelor’s degree in Engineering/Math/Science and 8–10 years of medical device quality experience, with strong regulatory and leadership skills to drive