Sr Quality Engineer

Overview

Senior Quality Engineer –

Location:

Racine, WI – Hybrid

Are you ready to play a pivotal role in ensuring the quality and safety of life-changing medical devices? Our client is looking for a driven Quality Engineer or Senior Quality Engineer to join their team. You ll work across departments, from R&D to operations, ensuring compliance with regulatory standards and improving processes that directly impact the healthcare industry. Join a family-owned company committed to improving lives around the world through cutting-edge medical innovations!

• Work with innovative products that improve global healthcare.
• Opportunity to lead quality improvement initiatives across various departments.
• Comprehensive benefits, including medical, dental, vision, and 401(k) from day one.
• Generous paid time off (20 days) and 15 paid holidays.
• Paid parental leave and employee bonuses.
• Amazing Salary and Benefit Package.

• Leading or supporting change control, NCR, CAPA, and quality surveillance activities.
• Conducting risk management and design control processes for product changes and new product launches.
• Engaging in internal and external audits, ensuring compliance with regulatory bodies.
• Driving quality improvement initiatives to enhance efficiency and reduce defects.
• Managing adherence to regulatory standards, including ISO 13485 and FDA Quality System Regulations.

• Bachelor’s degree in Physical Science, Engineering, or equivalent experience.
• Strong knowledge of FDA regulations, ISO 13485, and risk management (ISO 14971).
• Expertise in NCR/CAPA processes and electromechanical device validation.
• Proficient in software integration and auditing, with excellent communication skills.

We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to  and tell me why you’re interested. Or, feel free to email your resume. Please include Job#18914.