Cardiocom is an award-winning leader in cutting-edge telehealth solutions, medical software and nurse call center services located in Chanhassen, Minnesota. With a client roster that includes some of the largest home health groups, health plans, hospitals, physician groups and coordinated care companies in the nation, Cardiocom is positioned to revolutionize this fast-growing industry. Take the next step in your career! Join a progressive, dynamic and vibrant company that’s on the leading edge of telehealth. We look forward to hearing from you.
As a result of our dynamic growth, we have an outstanding opportunity for a full-time Quality Engineer. We are looking for enthusiastic professionals with two or more years of medical device quality assurance and a working knowledge of product development and design control. If you thrive in an innovative, fast-paced, team oriented environment, Cardiocom can offer you the opportunity for a successful career.
The Quality Engineer is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within new product development, manufacturing and post-market surveillance.
- Lead in the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements
- Lead in development and execution of supplier corrective actions
- Provide sound design control/risk management expertise regarding development projects, design changes and post-market surveillance
- Identify, implement and maintain processes that can improve the regulatory compliance, quality and performance of Cardiocom products
- Assist manufacturing in performing equipment qualifications and process validations
- Develop and maintain Risk Management Plans/Reports
- Lead in the completion and maintenance of risk analysis
- Work with engineering in the completion of product verification and validation
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Complete batch record review as needed
Our ideal candidate would also have:
Education: A minimum of four-year engineering or science degree or equivalent
Experience: Two or more years of experience in medical device quality assurance. Working knowledge of product development process and design control.
- Ability to interface with all groups and levels to solve problems and create solutions.
- High level of verbal and written communication skills and technical writing
- Ability to manage multiple projects
- Ability to work independently with minimal supervision
Salary, Benefits and Other:
- Salary based on experience.
- Cardiocom offers a dynamic team environment with a great benefits package that includes medical, dental, vision, 401K, flex spend, life and PTO.
- Excellent opportunity for growth and advancement.
Cardiocom is an EEO/AA employer.
For more information on Cardiocom and its services, visit www.cardiocom.com
Local candidates only please.