Abbott Supplier Assurance Engineer II in St. Paul, Minnesota
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.
This position is responsible for conducting worldwide quality system audits of critical suppliers, and supporting other qualification activities to establish and maintain suppliers on the global Approved Supplier List.
Acts as certified lead auditor in auditing supplier quality systems.
Contributes to supplier audit schedule planning and resource planning.
Researches global performance information data from SJM sites and communicates with stakeholders
Determines audit scope and type
Independently schedules audits with suppliers to best mutual time.
Establishes audit agenda and provides advance review of audit scope with supplier.
Arranges air, hotel and rental car accommodations in accordance to Abbott guidelines.
Conducts all audit activities including opening and closing meetings
Defines activities and responsibilities for other auditors on the audit team
Prepares audit report and issues audit corrective actions to supplier.
Follows through on corrective actions, verification of effectiveness, and timely closure of audit report.
Leads other supplier qualification activities including solicitation, review and approval of quality system assessments, and supplier quality agreements.
Provides team support for business and product transfer teams relative to supplier qualification.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
Performs other related duties and responsibilities, on occasion, as assigned.
BS degree in Engineering or Technical Field or equivalent experience.
3-5 years’ experience in the medical device industry, including auditing per ISO and/or FDA standards.
Lead Auditor certification training to ISO 13485:2003.
Engineering experience in medical device manufacturing related process controls.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization and suppliers.
Excellent writing skills are required
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel up to 50%, mostly USA, but potential international.
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 email@example.com