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Quality
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18000D21 Requisition #
Thanks for your interest in the Quality Systems Specialist position. Unfortunately this position has been closed but you can search our 1,343 open jobs by clicking here.

Must Haves:
 
EDUCATION REQUIRED: 
• Bachelor degree


YEARS OF EXPERIENCE:  
• 2+ years QS or QC related experience in FDA/GMP regulated industry including involvement with internal/external auditors.
• 2+ year general laboratory experience.

 

Nice to Have – (Preferred Qualifications):

 

• BS/BA degree preferably in Engineering or Life Sciences.  
• Working knowledge with the handling of bio hazardous materials preferred
• Working knowledge of laboratory analytical methods and techniques.
• Excellent computer skills to navigate various systems and investigate the complaint records as needed.  Examples of systems include: SAP and Trackwise.
• Proficient with computers to conduct through complaint investigations and research.
• Excellent working knowledge of MS Word, Excel and Power Point.
• Excellent verbal and written communication skills, including the ability to develop and present technical information necessary for the company.
• Excellent communication and follow-up skills to investigate and seek additional information for complaints.
• Consistently demonstrates ability to manage multiple tasks and complete daily work schedule actions in a timely manner.
• Demonstrates proficiency to read, train to and apply all the regulatory requirements for Complaint Handling and Medical Device Reporting.
• Exemplifies ability to work in a team environment and foster team work.
• Ability to demonstrate a high standard for accountability, work ethic and dedication to tasks and assignments.
• Good problem solving and investigation skills.
• Good critical thinking skills.
• Good analytical skills including ability to analyze/identify problems and recommend solutions.
• Excellent interpersonal skills.
• Working knowledge of FDA 21CFR 820, 803; ISO 13485, Medical Device Directive and applicable Harmonization Standards that apply to medical devices desired.

 


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.

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