Principal IT Business Analyst (Quality & CAPA)
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MUST HAVE (Minimum Qualifications)
• Bachelor’s Degree
• 7+ years of IT experience with a Bachelor’s Degree or 5+ years of IT experience with an advanced degree
NICE TO HAVE
• 5+ years of quality assurance and/or regulatory experience
• 3+ years of CAPA related experience in FDA/GMP regulated industry including involvement with internal/external auditors.
• Working knowledge of root cause analysis and techniques.
• Excellent verbal and written communication skills, including the ability to develop and present technical information necessary for the company.
• Consistently demonstrates ability to manage multiple tasks and complete daily work schedule actions in a timely manner.
• 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, investigation, and critical thinking skills.
• Good analytical skills including ability to analyze/identify problems and recommend solutions.
• Project management skills (planning and estimating phases, work and task breakdown structures, set milestones, remove barriers to meet milestones).
• Working knowledge of FDA 21CFR 820, 803; ISO 13485, and other applicable Standards that apply to medical devices desired.
• Good understanding of:
o Software development methodologies
o IT system environments and maintenance activities
o Quality and regulatory regulations required for the medical device industry
o CAPA and Audits
• Other ideal preferences include:
o Experience with multiple system development life cycles (e.g., waterfall, agile, iterative, etc.)
o TrackWise tool experience
o CSTE or CSQA Certification
o ITIL Certification
o PMP Certification
o Green Belt Certification
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.
DISCLAIMER
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.
