Sr Compliance/Audit Specialist - Manufacturing R&D
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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.
Must Have: Minimum Requirements
Nice to Have
- Minimum of 4 years experience, or advanced degree with a minimum of 2 years experience
- Bachelor's Degree Required
- Certified Lead Auditor from a recognized professional organization or an accrediting organization per a Quality Management System schema or standard.
- Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA GMP QSR and ISO 13485, and MDSAP) for finished medical devices with the ability to effectively implement and communicate those requirements in a government regulated healthcare industry
- Effective usage of data analysis tools, analytical and research skills, and problem solving techniques with keen attention to detail and simultaneous understanding of the "big picture". Desire to follow an audit trail to identify risks, non conformances, true root cause, etc.
- Outstanding written, oral communication, and presentation skills
- Sound judgement, ability to make decisions, work independently, demonstrated leadership skills
- Ability to manage and execute on multiple critical projects simultaneously. Capable to manage multiple priorities and escalate issues.
- 2 or more years experience in the manufacturing setting
- Experience supporting and or participating in regulatory inspections and audits.
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.
