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? My 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!
Why You Should Apply
- 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.
What You’ll Be Doing
- 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.
About You
- 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.
How To Apply
We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to laura@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume. Please include Job#18914.