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 114,000 colleagues serve people in more than 160 countries.

Supervisor Document Control

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.Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with a high employer contributionTuition 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 worldwide 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 diversity, working mothers, female executives, and scientists.

The Opportunity

Responsible for developing, implementing, maintaining systems and procedures to support the company wide document control and product lifecycle management system. This shall be accomplished in accordance with applicable domestic and international regulations and standards.

What You’ll Work On

Responsible for implementing and maintaining the effectiveness of the quality system.Ensure systems and policy compliance to FDA QSR, ISO9001, and ISO13485.Develop, report and analyze key metrics to track Document Control System effectiveness.Manages the daily activities of the department by establishing priorities, work schedules, problem solving, and customer service.Defines and allocates resources needed to meet established project schedules.Exercises judgment in planning and organizing work; monitors performance and reports status.Build and maintain successful cross functional relationships with internal departments such as: manufacturing, Quality Control, Regulatory Affairs and Operations.Participate in project teams to further develop efficient and effective use of Document Control services.Participate, along with manager, in Corporate, Divisional and external regulatory agency audits or inspections.Supervise and train Document Control staff in adhering to policies and procedures in addition to daily requirements.Coaching and mentoring of staff in order to develop staff and maintain a positive work environment.Ensure the Document Control department provides document and change support to its internal customers.Develop, report and analyze key metrics to track Document Control process/system effectiveness.Either on own or with manager, report these metrics at the Executive Management Review meetings.Management of approval and notification groups in Agile.Configure new approval groups by working with other departments within ADC in order to streamline approval process.Help management of user and supplier accountsCoordinate/manage new product launches within Document ControlBuild and maintain successful cross functional relationships with internal departments such as Manufacturing, Quality, Regulatory Affairs, R&D, ALD, Operations.Support all aspects of the CAPA process for Document Control.Process change packages in the PLM/DMS application.

Required Qualifications

Bachelors Degree or equivalent to 10+ years experience2-3 years experience with a Change Order system in the Medical Device or similar industry.Firm knowledge of Quality System requirements.Strong hands-on experience, supervisory skills and mentoring of department staff.Expert use of various software applications such as MS Word, Excel, Teams, etc.1-2 years Administrative use of Agile Electronic Document Management system or other document management system.The supervisor will need to be able to react quickly to needs both from within and outside the business. He/She will need to identify exactly what the problem is and will need to be aware of the impact any solutions will have to the rest of the company or to TPMs/suppliers. He/She will need to be able to balance the workload within the Document Control department.Requires knowledge of ISO 9001, ISO 13485, or 21CFR820.

Preferred Qualifications

Well developed written, oral and organizational skills.Project management experience preferred

Apply Now

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The base pay for this position is $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted.