Veterans at Abbott
Abbott Manager Documentation Services in Plymouth, Minnesota
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries
EPHF Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.
WHAT YOU’LL DO
Working within broad objectives from the Quality Department, is accountable for developing and executing all activities related to management of documentation. The activities include Change and Document Control, Change Control system maintenance, and Quality Records retention. These activities are required to be in accordance to the U.S. Food and Drug Administration (FDA), Good Manufacturing Practice (GMP), and other International Regulatory Requirements such as the International Organization for Standardization (ISO) requirements series. Provide leadership for the Electrophysiology (EP) Business Unit as well as support other Business Unit documentation system programs. Responsible for coordinating documentation efforts across manufacturing and development. Uses best business practice to ensure success in areas of responsibility. Supports the Legal Department in the research and production of documents for litigation as requested.
Responsible for hiring and retaining a diverse, highly qualified staff and for providing career coaching, growth, and personal development. Accountable for the staff development; provides feedback, instructs, mentors, evaluates, and coaches. Accountable for the performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong customer focus.
Manages the daily activties of the department by establishing priorities, work schedules, problem solving, and customer service. Sets goals, ensures that they are met and is responsible for continuous process improvement. Ensures employee compliance with Abbott and Division policies.
Defines and allocates resources needed to meet established project schedules. Exercises judgment in planning and organizing work; monitors performance and reports status
Develops and controls department budget.
Ensures documentation activities are in compliance to ISO and 21CFR 820 Quality System Regulation.
Develops process flows to coordinate documentation change control activities
Conducts research for Legal Department during litigation
Responsible for maintenance and control of Quality records including the Device Master Record.
Provides documents and historical records regarding during internal and external audits.
Troubleshoots, resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence
Collaborate with IT to drive prioritization of system enhancements based on business need. Provide input to documentation and testing of system enhancements.
Ensure procedures remain aligned and appropriate for execution of Change Control and Records.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION AND EXPERIENCE YOU’LL BRING
A Bachelor’s Degree in Engineering, Science, a related field or equivalent.
Minimum of ten years of progressively more responsible documentation management experience.
Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position. Must be skilled at delegation, follow-up, database management tools, document control procedures, and team building
Experience working in a broader enterprise/cross division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
Ability to work effectively within a team in a fast-paced changing environment.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multi-tasks, prioritizes and meets deadlines in timely manner.
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development , with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org