Senior Quality Engineer – Medical Device QMS & Design Controls

Resonetics; New Chicago (OH); On-site; USD 78,000 - 124,000; Full time

Job summary

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. The Sr.

Quality Engineer is a key member of the Quality Assurance team, ensuring QMS compliance and supporting design controls, validation, risk management, and post-market activities. The role reports to the Director of Quality Assurance and Regulatory Affairs and collaborates across development teams.

Qualifications

• 5+ years of experience in a Quality Engineering role.
• Bachelor's degree or equivalent experience required.
• Demonstrated technical writing and communication skills.
• Strong attention to detail and organizational skills.
• Ability to lead product verification & validation activities.

Responsibilities

• Ensure product quality, safety and effectiveness and investigate customer complaints.
• Ensure compliance with QMS and regulatory requirements across development.
• Collaborate with design and development teams to support design controls.
• Prepare qualification/validation protocols and support design deliverables.
• Perform risk assessments and implement CAPA and change controls.
• Mentor junior engineers on quality system requirements.

Skills

Technical writing

Communication skills

Attention to detail

Leadership / mentoring

Education

Bachelor's degree or equivalent experience

Tools

Word

Excel

PowerPoint

Job description

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. The Sr.

Quality Engineer is a key member of the Quality Assurance team, ensuring QMS compliance and supporting design controls, validation, risk management, and post-market activities. The role reports to the Director of Quality Assurance and Regulatory Affairs and collaborates across development teams.