Alameda, CA, United States
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 103,000 colleagues serve people in more than 160 countries.Provide strategic and functional leadership of QA activities for suppliers ensuring compliance to applicable regulatory requirements and Quality Agreements and in co-operation with all relevant functions. Manage a staff of Supplier Quality Engineers to support the supplier role and responsibilities. Ensure that TPMs and suppliers perform and document the appropriate engineering approach for activities such as qualification and validation of processes, methods, and equipment, and assist in these efforts, as appropriate, to ensure safe, efficacious and quality product are supplied in accordance with regulatory and business requirements.Responsibilities:- Monitors supplier performance and reports supplier quality trend data to upper management.- Supports supplier continuous improvement plans and activities.- Serves as a Subject Matter Expert during Internal and External inspections.- 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.- Responsible for assuring the development of the Supplier Quality Engineering staff, providing growth plans and professional guidance, as appropriate.- Evaluate and approve supplier requested changes or improvements. This activity may include changes such as the identification and/or approval of a new supplier to provide an alternate material, site change, and manufacturing process changes.- Develop and consistently execute a quality strategy for TPM /Suppliers to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.- Direct the Supplier QA team to ensure that the commitments of the Quality Agreements are being fulfilled and help facilitate resolution in cases where they are not.- Develop and Lead goals with cross-functional/global scope.- Lead and participate on QA cross-functional teams to support TPM and suppliers, including active participation in Business Management Reviews as necessary.- Support long-range planning efforts for capacity (people, systems).- Ensure timely handling of supplier exceptions with impact on product quality, safety, efficacy and impact to the regulatory filing.- Provide a Quality Assurance service with regards to guidance on validation strategies; guidance on product, process, equipment, analytical which may or may not require a re-validation.- Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for TPMs and Suppliers, that identify and address quality, operational, and organizational issues.- Promote continuous improvement, innovation, simplification aligned with Abbott and division strategy.Qualifications:Bachelors Degree preferably in the life or physical science or engineering, Bioengineering or other science disciplines. 6 years of experience in Supplier related functions. Minimum 4 years experience in Quality Assurance/Regulatory in company with medically focused manufacturing environment. Minimum 4 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 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.,datePosted:2019-07-17T00:00:00.000Z,title:Manager Supplier QA,occupationalCategory:Quality,@context:http://schema.org} Manager Supplier QA job | Abbott Laboratories United States job in Alameda, California, United States of America
Website : http://www.abbott.com
We’re dedicated to fulfilling the promise of human potential, in all places, in all aspects and stages of life. We believe that health is the key to that promise. Because at our healthiest, we’re capable of achieving anything. And that’s why our pursuit of helping people achieve their best health at every life stage will never end. This is how we put that belief into practice each and every day.