Medical Device Quality Engineer I

Argentum Medical; Geneva (IL); On-site; USD 80,000 - 85,000; Full time

Job summary

Bioderm in Geneva, IL is seeking a Quality Engineer I to support the Quality Management System and provide quality engineering services across design, development, production and post-market surveillance activities. Reports to Quality Manager.

Responsibilities include SOPs, training, supplier management, CAPA/SCAR, and cross-functional teamwork toward process improvements and product quality.

Qualifications

• Bachelor’s degree in Engineering, Microbiology, Chemistry, or equivalent.
• Minimum 1 year in Microbiology, Chemistry, or as a Quality Engineer.
• Experience in highly regulated environments (medical devices, food, pharmaceuticals, automotive, or aerospace).
• Basic statistics experience.
• Six Sigma and Lean background.

Responsibilities

• Support analytical lab for testing, verification and validation of substrates and fabrics.
• Create and maintain SOPs, Validation and Quality Control Plans.
• Create, maintain training system and supplier files.
• Support QA/Manufacturing to produce quality under quality standards and testing requirements.
• Assist cross-functional teams to develop new products, processes and test methods.
• Assist with development of medical device products from concept through scale-up.
• Create acceptance criteria and sampling plans for production.
• Support equipment, product and software Validation (IQ, OQ, PQ, TMV).
• Maintain the Device Master Record (DMR).
• Assist with customer complaint records and investigations.
• Generate CAPA and SCAR and follow-up audits.

Skills

Six Sigma

Lean processes

Analytical thinking

Statistics basics

Education

Bachelor's degree in Engineering

Equivalent work experience

Job description

Bioderm in Geneva, IL is seeking a Quality Engineer I to support the Quality Management System and provide quality engineering services across design, development, production and post-market surveillance activities. Reports to Quality Manager.

Responsibilities include SOPs, training, supplier management, CAPA/SCAR, and cross-functional teamwork toward process improvements and product quality.