Senior Principal Compliance/Audit Specialist
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IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME:
REQUIRED EDUCATION:
• Bachelor’s Degree in Quality, Engineering, or other technical discipline
REQUIRED YEARS OF EXPERIENCE:
• 10+ years of experience in the medical device or other regulated industry
• 2+ years of experience in quality system auditing
SPECIALIZED KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
• Experience with FDA 21 CFR Part 820 and other applicable regulations
• Experience with ISO 13485 and other applicable standards
• Experience performing audits in the area of quality systems
• Experience with Word, Excel, PowerPoint, Outlook
DESIRED/PREFERRED QUALIFICATIONS AND SPECIALIZED KNOWLEDGE:
• CQA (Certified Quality Auditor) Certification or registered lead auditor with notified body
• Experience with international regulations
• Demonstrated excellent written and oral communications with the ability to influence and interface across the organization
• Experience and education in analyzing and selecting a sample size for auditing purposes
• Advanced presentation skills
• Excel at project planning and project management
• Strong business acumen
• Pro-active, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
• Able to work effectively in teams or as a leader
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.
• 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 for extended periods of time, and communicate with peers and co-workers.
• Must be able to travel both domestically and internationally, up to 50% of the time
• Must be able to travel independently to various Medtronic buildings/sites
ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
