What are the responsibilities and job description for the Supervisor Document Control position at Abbott?

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 accounts
Coordinate / manage new product launches within Document Control
Build 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 experience

2-3 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

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