Sr Quality System Specialist - Post Market Surveillance
Bachelor's degree
Nice to Have
• Strong attention to detail
• Knowledge of basic anatomy, physiology and medical terminology
• Knowledge of:
- 21CFR, Section 820, Quality System Regulation
- 21CFR Section 803, Medical Device Reporting
- ISO 13485, Quality Systems, Quality Management Systems
- 45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations
- AIMD Directive: 90/385/EEC
- IVD Directive: 98/97/EC
- MDD Directive (Council Directive 93/42/EEC for Medical Devices)
- PC 1998-783 - Canadian Medical Device Regulation (CMDR)
• Strong analytical skills (problem solving, critical thinking)
• Excellent communication skills (oral and written), with strong organizational and analytical skills
• Ability to work independently or in a team setting
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.