Company Summary:

Centese, Inc. is a fast-paced start-up medical device company developing products to improve outcomes for patients undergoing heart and lung surgery. The first product, Thoraguard, is a fully automated chest tube and chest drainage system at the intersection of patient-centric outcome improvement and digital medicine. We are building a team of multidisciplinary experts passionate about positively impacting the lives of others through technological advancement.

Job Summary:

As Quality Associate at Centese, you will oversee and maintain the company’s QMS procedures and controls to comply with ISO and regulatory requirements. You will also critically assess the effectiveness of the QMS to meet the company’s quality objectives, including through regular management reviews and internal audits, and implement improvements where appropriate. This role requires close collaboration with personnel in Operations and Engineering, as well as interactions with outside vendors and internal customer service teams to facilitate the process of building and delivering product to customers.

Key Responsibilities:

• Ensure QMS complies with regulatory requirements including 21 CFR Part 820 and ISO 13485
• Serve as management representative for company’s QMS
• Oversee day-to-day operations of the company's document control system
• Plan and conduct internal quality system audits
• Plan and conduct quality management reviews to evaluate the performance of the QMS
• Track and communicate quality metrics to assess the performance of the QMS
• Maintain audit and inspection readiness and serve as quality subject matter expert within company
• Ensure personnel throughout the company are trained on QMS and compliant with its procedures
• Manage approve supplier list including regular re-evaluation and audit of suppliers
• Manage non-conformances and coordinate activities across departments through completion
• Perform lot review and release for production builds
• Manage equipment calibration and preventive maintenance schedules

Required Qualifications:

• Bachelor’s degree in engineering or science
• 5+ years of quality assurance experience
• Deep understanding of 21 CFR 820 and ISO 13485 or 9001
• Exceptional problem-solving and organizational skills
• Solid understanding of principles for design and process validation
• Excellent interpersonal and communication skills
• Ability to understand basic principles of engineering and physiology

Preferred Qualifications:

• Experience within the medical device industry

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Paid Time Off
• Sick Leave
• Short & Long-Term Disability
• Life Insurance
• 401(k) 
• Wellness Program