Responsible and accountable for incoming, in-process, and final inspections of medical devices and components.
Manages the Non-Conforming Material and Material Review Board processes.
Trains, manages and mentors inspection staff.
Schedules, manages and documents supplier audits.
Primary Responsibilities and Functions:
Manage Quality Control activities to ensure that production plans and objectives are completed.
Manage the Manage the Non-Conforming Material and Material Review Board processes.
Perform and supervise inspections in a cleanroom environment.
Support external audits by FDA and European notified body.
Assist in development and execution of test protocols, corrective action plans, and quality events.
Develops and /or assists in the development of new inspection, testing and assembly processes.
Completes and files quality records including travelers, inspection reports, NCMRs, supplier notifications, and ROs.
Assist with complaint investigations, complaint reports, and failure analyses.
Performs audits of suppliers and internal functions.
Assists Engineering, Materials and Manufacturing areas as needed to support products, component validation and testing.
Participate on design teams as Quality Assurance representative.
A minimum of 5 years Quality Control experience. Medical device industry experience is preferred.
Working knowledge of FDA QSR and ISO 13485 requirements
Proficiency with Microsoft Office applications
Familiarity with auditing procedures and techniques
Additional Salary Information: We offer a competitive salary and a comprehensive employee benefits package including PTO, short and long term disability coverage, medical, dental, vision, life and accident insurance and a 401(k) plan with company matching. Eligibility for all benefit plans is immediate.
CardiacAssist, Inc. is a medical device company headquartered in the RIDC complex near Aspinwall, PA. We offer an array of products including the TandemHeart, an extracorporeal circulatory support system and the TandemLung oxygenator, which are used in hospitals across the U.S. and internationally. We employ engineers, technicians, product assemblers, marketing, customer service and support staff at our headquarters location and clinical/sales staff across the country.