Senior Quality Engineer - QMS & Design Controls Lead

Resonetics; Dayton (OH); Sur place; USD 78 000 - 124 000; Plein temps

Résumé du poste

Resonetics in the United States is seeking a Sr. Quality Engineer to join the Quality Assurance team, focusing on implementing and maintaining the QMS to ensure regulatory compliance in medical device development and manufacture.

You will lead design controls, risk management, verification/validation activities, CAPA, and audits, collaborating with engineering, manufacturing, and suppliers to drive quality across the product lifecycle.

Qualifications

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

Responsabilités

• Ensure product quality, safety and effectiveness, and investigate customer complaints.
• Ensure QMS compliance with regulations and standards throughout product development.
• Collaborate with development engineering to support Design Controls documentation.
• Lead or support qualification/validation protocols for design deliverables.
• Conduct risk assessments and implement mitigating actions.
• Manage CAPA, change control, audits, and DHF/DMF documentation.
• Mentor junior engineers on quality system requirements.
• Collaborate with internal teams and suppliers on root cause analysis and corrective actions.

Connaissances

Quality Engineering

Regulatory Compliance

Technical Writing

Design Controls

Risk Management

CAPA

Documentation

Supplier Quality

Leadership

Analytical Skills

Formation

Bachelor's degree

Outils

MS Word

MS Excel

MS PowerPoint

Description du poste

Resonetics in the United States is seeking a Sr. Quality Engineer to join the Quality Assurance team, focusing on implementing and maintaining the QMS to ensure regulatory compliance in medical device development and manufacture.

You will lead design controls, risk management, verification/validation activities, CAPA, and audits, collaborating with engineering, manufacturing, and suppliers to drive quality across the product lifecycle.