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.

     

JOB DESCRIPTION:

What You’ll Work On

• Manages a group of individuals who have responsibilities in the selection, qualification, and ongoing monitoring of suppliers including maintaining the Approved Supplier List (ASL), auditing suppliers, monitoring supplier performance, qualifying potential suppliers, oversight of supplier corrective action records (SCARs) and control of incoming materials.
• Apply QSR 21 CFR Part 820 (Medical Devices) to the everyday application of Supplier Quality Management activities.
• Support the creation and management of quality agreements with suppliers.
• Manage supplier change control and work with the Operation/Quality Engineering group to evaluate the change impact on product performance.
• Chairs the Supplier Quality Review Board and generates metrics for Quality Management Review to actively monitors supplier performance and the health of purchasing controls
• Assures that incoming components have suitable process controls to assure they consistently perform to assure product performance and oversees the Quality Incoming Inspection team, assuring that specifications are met. 
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has 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
• Carries out duties in compliance with established business policies
• Other duties as assigned, according to the changing needs of the business

Required Qualifications ​

• Bachelor's Degree in a biological science or engineering discipline or a mix of education and equivalent relevant experience.
• 8 yrs of Supplier Quality or Supply Chain management experience
• Regulated Manufacturing - such as working understanding of regulations relating to in-vitro diagnostic medical device products (e.g. 21CFR Part820, EN ISO 13485, EN ISO 14971, CMDR).  Specific experience with 21 CFR 820.50.
• Worked on Global Teams and have cultural awareness
• Ability to travel approximately 10% domestic and international

Preferred

• People Management experience
• Multi-Site or Multi-Entity responsibility
• Industry experience in Medical Devices, IVD, Nutrition, or Pharma
• Ability to read, interpret and understand technical and non-technical documents including product drawings, specifications, contracts, and purchase orders   Experienced in root cause analysis and corrective action processes.
• ASQ Certified Quality Engineer or equivalent experience desired
• Must be able to demonstrate the ability to be a part of a team (e.g. Procurement, Manufacturing, R&D, Quality, and Working with a site leadership team).

     

The base pay for this position is

$128,000.00 – $256,000.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

CMI ARDx Cardiometabolic and Informatics

        

LOCATION:

United States > San Diego : 7220 Trade Street, Suite 395

     

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), 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