Medical Devices Quality Engineer

Stevanato Group; Fishers (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

None

Job summary

Stevanato Group in Fishers, IN is seeking a Quality Engineer to support the Quality Management System, Product Realization, and Manufacturing Process Controls. You will collaborate with cross-functional teams to ensure product quality and regulatory compliance.

The role emphasizes CAPA leadership, data-driven problem solving, and validation activities, with expected responsibilities for audits, documentation, and process improvements in a manufacturing environment.

Qualifications

• 3-5 years experience in Quality Assurance/Quality Engineering/Process Engineering in manufacturing.
• Bachelor's degree in a technical field (Engineering, Material Science, Data Analytics, Statistics) or equivalent work experience.
• Strong communication, problem solving, and project management skills.
• Knowledge of ISO 9001, ISO 13485, and FDA cGMPs.

Responsibilities

• Monitor and report quality metrics; assess product performance data using statistical methods.
• Lead CAPA investigations, trend deviations, and customer complaints to drive quality improvements.
• Prepare and review validation activities, qualification plans, and internal/external reports.
• Collaborate with Operations and Engineering to ensure qualification/validation activities meet plan requirements.
• Support quality documentation, guidelines, and procedures in line with regulatory standards.
• Participate in quality audits/inspections and provide data-driven support.

Job description

Stevanato Group in Fishers, IN is seeking a Quality Engineer to support the Quality Management System, Product Realization, and Manufacturing Process Controls. You will collaborate with cross-functional teams to ensure product quality and regulatory compliance.

The role emphasizes CAPA leadership, data-driven problem solving, and validation activities, with expected responsibilities for audits, documentation, and process improvements in a manufacturing environment.