Abbott Senior Change Specialist in Minneapolis, Minnesota
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
This position is responsible for establishing and maintaining Quality documentation system, ensuring documentation is in accordance with established procedures and regulations, as well as initiating and managing continuous improvement projects involving multi-functional or multi-site groups and issues.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Establish, prepare, manage and implement the Quality documentation system;
Manage the complete documentation life cycle;
Ensure documents are reviewed for consistency with similar or related product specifications and / or labeling;
Responsible for documentation related to new product development life cycle management such as but not limited to Design History File - (DHF), Design Development Plan (DDP), and Design Control;
Serve as Subject Matter Expert (SME) on documentation related matters to support the business cross-functionally; work independently and in cross-functional project teams;
Other duties and responsibilities as assigned;
Follow all EHS rules and procedures for your department. Report any EHS incidents and / or Near Misses (unsafe acts and conditions) promptly to supervision. Forward any opportunities to improve the EHS program to supervision.
Responsible for implementing and maintaining the effectiveness of the Quality System.
Position Accountability / Scope:
Responsible for compliance to industry standards. Makes timely and effective decisions related to business issues within scope of responsibility. Appropriately elevates high risk issues / decisions. The incumbent should possess competence and credibility.
Minimum Education :
Bachelor's degree, preferably in a science or engineering discipline; equivalent experience is acceptable as an alternate to education requirement.
Minimum Experience / Training Required:
Typically requires at least 6 years of relevant experience in a technical, quality or operational function within a regulated industry to satisfactorily meet the core job responsibilities of the position;
Candidate / incumbent should possess:
Ability to understand technical information
Knowledge of regulations and standards affecting IVDs and medical devices is desired;
Excellent written, verbal and interpersonal communication skills;
Ability to evaluate complex processes and apply critical-thinking skills;
Ability to interact effectively with all levels of employees; consistently displays socially and professionally appropriate behavior
Knowledge of electronic word processing and other office software applications
Training to perform activities will be conducted in accordance with the approved Training Plan
ASJM Abbott St. Jude Medical
United States > Minnesota : 5050 Nathan Lane N.
Yes, 5 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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