Quality Supplier Engineer

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 109,000 colleagues serve people in more than 160 countries.

S tructural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

Our location in St. Paul, MN, currently has an opportunity for a Supplier Quality Engineer II. This position will manage suppliers for Structural Heart, ensuring purchased materials meet specifications

WHAT YOULL DO

• Execute and support on-time completion of Design Control Deliverables
• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
• Lead or support Risk Management activities from product Concept through Commercialization
• Support design test and inspection method development, and lead method validation activities
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Support manufacturing process development & qualification for new product commercialization and product changes
• Support internal & external audit responses
• Support product re-certifications
• Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
• Support execution of biocompatibility and sterilization qualifications
• Complete Document Change Request Reviews in a timely and objective manner
• Manage Supplier Corrective Action Requests (SCARs)
• Manage Supplier Change Notifications (SCNs/SCRs)
• Manage Nonconforming Material reports (NCMRs)
• Additional duties may be identified by functional management based on the current project/business objectives.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• 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 vendors.

EDUCATION AND EXPERIENCE YOULL BRING

Required

• Bachelors Degree in Engineering or Technical Field or an equivalent combination of education and work experience
• 2+ years Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
• 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.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Production areas that are clean, well-lit and temperature-controlled
• Training and career development , with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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