Scientific Search · 1 hour ago
Sr Quality Engineer
Racine, WI
Full-time
Hybrid
Senior LevelScientific Search is a family-owned company committed to improving lives around the world through cutting-edge medical innovations. They are seeking a Senior Quality Engineer to ensure the quality and safety of life-changing medical devices by working across departments to ensure compliance with regulatory standards and improve processes.
Human ResourcesStaffing Agency
Responsibilities
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
Qualification
Required
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
Benefits
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.
Company
Scientific Search
Scientific Search is a staffing and recruiting company offering pharmaceutical, engineering, and it recruiting services.
Founded in 1983
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase