Abbott Sr Manager Supplier QA in Abbott Park, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Overall responsibility for developing, implementing, and maintaining all aspects of the Supplier Quality Engineering program and ensuring the necessary systems and procedure are established to support the needs to the corporation.
Oversees all functions of the Supplier Quality Management program, including supplier evaluation, approval and maintenance. Oversees strategic supplier management programs such as Supplier Certification, Alternative Inspections Methods, Supplier Performance Monitoring, Continuous Improvement Initiatives etc.
Ensures the implementation of company-wide quality systems and policy compliance to FDA QSR, and ISO9001/13485 as they relate to supplier management. Manages a staff of Supplier Quality Engineers in order to support the supplier management program for the business.
Responsible for implementing, and maintaining the effectiveness of the Quality System as it relates to Supplier Quality Management. Develop, prioritize, provide direction and monitor progress toward Supplier Quality Engineering department goals and objectives. Manages Supplier Quality Engineers to ensure ample coverage and support for engineering projects and product release activities as related to supplier management.
Ensures the ADC Approved Supplier List is maintained and accurate.
Monitors supplier performance and reports supplier quality trend data to upper management.
Supports supplier continuous improvement plans and activities.
Responsible for assuring the validation and qualification of processes, methods and equipment at suppliers.
Responsible for assuring the performance of all required supplier maintenance activities such as quality system assessments and process assessments at suppliers.
Serves as the Subject Matter Expert during Internal and External inspections.
Responsible for assuring the development of the Supplier Quality Engineering staff, providing growth plans and professional guidance, as appropriate.
Establish and maintain successful cross-functional relations with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, and Quality Systems departments.
Manages Supplier Quality budget.
Bachelor’s Degree; preferably in the life or physical science or engineering Bioengineering or other science disciplines 10 years of experience in Supplier related functions. A minimum of 4 year’s experience in Quality Assurance/Regulatory in company with medically focused manufacturing environment. Minimum of 6 years in management of direct resources or cross functional teams. Working knowledge of regulations and standards affecting Medical Device manufacturing (e.g. QSR, ISO, EN Quality System Requirements).
Demonstrated experience with development, implementation and management of company-wide quality system procedures/practices.
Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects, influence internal and external groups and provide leadership from a quality perspective.
Highly developed written, oral and interpersonal skills, strong statistical application experience and proficient use of various software applications such as MS Word, Excel, Access and statistical analysis tools.
The incumbent should have a proven record of leadership with strong organizational and human relations skills. This includes the ability to deal with multidisciplinary functional areas within the division and the site.
Knowledge of Design Control, V&V operations and manufacturing practices is desirable. CQE, CQA, CQM via ASQ preferred.
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