Sr Compliance Specialist
Must Have: Minimum Requirements
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Bachelors degree required
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Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
NICE TO HAVE
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2 or more years relevant experience in the manufacturing setting
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Experience supporting and or participating in regulatory inspections and audits.
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Certified Lead Auditor from a recognized professional organization or an accrediting organization per a Quality Management System schema or standard.
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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. Special focus on Design Control processes/requirements.
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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.
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Outstanding written, oral communication, and presentation skills
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Sound judgement, ability to make decisions, work independently, demonstrated leadership skills
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Ability to manage and execute on multiple critical projects simultaneously.
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Capable to manage multiple priorities and escalate issues.
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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)