Supplier Quality Engineer II

Job description

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.

JOB DESCRIPTION:

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.

We are seeking a high caliber Supplier Development Quality Engineer II. This role would be responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. This position contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott standards and regulatory requirements. The person will represent Supplier Quality on new product development and product improvement projects in the Electrophysiology (EP) business unit.

This is an exciting time to be part of our EP department in the Twin Cities. This business unit has seen sustained revenue driving growth due to the success of our diverse product offering of class II and III devices spanning disposables to capital equipment. This Supplier Development Quality Engineer will provide component qualification support ranging from molded components to printed circuit boards, perform supplier and component related risk management activities, be the liaison between project teams and suppliers, and execute design controls.  

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take actions and accomplish goals.

Job Description:

• Partner with Supply Chain and extended project teams to assess supplier capabilities and historical performance to drive sourcing decisions in new product development.
• Develop project specific component validation strategies to plan, execute, and manage quality activities with suppliers, setting a high standard and fast response expectation so quality issues are prevented or minimized.
• Drive essential requirements based on risk management activities down to the component and supplier level.
• Develop and track component validation related metrics to report to the extended project team
• Provide validation training and consultation services on validation policies and practices to Abbott suppliers multiple tiers down the supply chain.
• Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures
• Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers
• Applies sound engineering analysis and judgement to reduce the need for inspection in accordance to program policies
• Review supplier validation documentation including but not limited to IQ/OQ/PQ, controls plans, process monitoring and first article inspections. Create and approve all supplied product drawings and component quality plans
• Review, analyze and provide recommendations for verification and validation test data.
• Contributes to the development, maintenance and improvement of Abbott supplier development quality program policies, procedures and forms
• Support other key processes as subject matter expert.

Required Qualifications:

• Bachelor's degree Engineering or Technical Field plus 2-5 years of related work experience with a good understanding of medical device design controls, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.  
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Strong organizational and follow-up skills, as well as attention to detail
• Demonstrated knowledge of manufacturing processes for commodities such as molded components, extrusions, machined components printed circuit board assemblies, cables, etc.
• Strong hands-on project management and teamwork skills with demonstrated ability to consistently establish and meet aggressive timelines. Demonstrated ability to build and maintain productive cross-functional and cross-organizational relationships on a global scale.
• Ability to leverage and/or engage others to accomplish projects, being adaptable to changing situations

Preferred Qualifications

• Engineering experience and demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Experience with PCBA and electronic components preferred
• Prior medical device experience preferred
• Knowledge of GDT and ability to interpret engineering drawings
• ASQ CQE or other certifications preferred

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