Document Control Manager

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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diverse, working mothers, female executives, and scientists.

The Opportunity
This position works out of our San Diego, CA, location in the Cardiometabolic and Informatics. Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.
As the Manager, Document Control, you'll have the chance to supervise the development, implementation and maintenance of the Change Management, Records Management and Training processes.
What You'll Work On

• This role is responsible for implementing and maintaining activities of the Document Control and Training staff; including Document Control Supervisors, Document Control Analysts, Document Controllers and Training Specialists. Assures that Document Control, change control and archival requirements outlined by the ARDx Policies, FDA, ISO and other appropriate regulatory agencies are met, maintained and optimized.
• Responsible for implementing and maintaining the Training department and assures that training requirements outlined by the ARDx Policies FDA, ISO and other appropriate regulatory agencies are met, maintained and optimized.
• Manages the administration of all Document Control and Training procedures.
• Develops and reports Document Control, change control and training key performance indicator metrics and change management statistical information to management team.
• Manages GMP records for cataloging, archival, retrieval and scheduled destruction of records in accordance with established procedures.
• Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Assist with equipment, process and facility qualification and validation activities as required.
• Assist and support internal audits and agency inspections/audits.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has an awareness of device defects that may occur in their area of responsibility, including product design, verification, and validation, manufacturing and testing activities.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships.

Required Qualifications

• Bachelor's degree or equivalent industry experience
• 3-5 years of experience in Quality Assurance, preferably in Document Control
• Minimum 3 years of experience in a supervisory position overseeing staff.
• Working knowledge of Quality Assurance in a medical device manufacturing environment

Preferred Qualifications

• Preferably in-vitro diagnostic industry experience
• Able to understand and adhere to quality documentation
• Compliance audit experience is preferred
• Position requires ability to jointly develop, implement, evaluate, and/or modify on going "best practices" to assure overall operational effectiveness
• Excellent organization skills - must be able to manage many simultaneous projects
• Attention to detail - must have precision in their work, especially as it relates to understanding and documenting complex quality issues.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The salary for this role is between:
$104,300 - $208,500
JOB FAMILY:
Operations Quality
DIVISION:
CMI ARDx Cardiometabolic and Informatics
LOCATION:
United States > San Diego : 9940 Mesa Rim Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time 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