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 an experienced, high caliber Engineer II Supplier Quality Engineer. Supplier Quality Engineers are responsible for activities related to supplier selection, evaluation, re-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 and regulatory requirements.
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.
IMPACT THIS ROLE WILL HAVE ON ABBOTT:
• Contributes to the development, maintenance and improvement of Abbott supplier development quality program policies, procedures and forms
• Provides Supplier quality focused Quality System Body of Knowledge support to Division and organization
• Works with product development and production to develop sound quality plans that effectively consider the impact of change(s) and the actions required for implementation.
• Ensures compliance to ISO 13485, 21CFR 820, MDR Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
• Analyzes quality audit findings and recommends modifications to products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
• Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements
• Performs re-evaluation of suppliers each year per a defined schedule
• Identifies supplier contacts and solicits required documents from suppliers
• Tracks supplier responses and conducts follow-up and escalation as necessary
• Conduct phone calls with supplier as needed to expedite responses or answer questions
• Reviews current Quality Agreements and determines need to revise
• Solicits revised Quality Agreements as determined
• Obtains and analyzes performance and quality indications information from internal sources for each supplier
• Prepares and submits required quality records for closure and filing.
• Reviews and approves all supplied product drawings and component quality plans
• Manages development of supplied product inspection procedures and first article requirements
• Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures
• Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits
• Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions
• Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews
• Contributes and participates in supplier performance reviews
• 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
• Works with Manufacturing engineering to assess and address purchased product issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Design and conduct experiments for process optimization and/or improvement
• Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)
• Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans
• 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
• Performs other related duties and responsibilities, on occasion, as assigned
• BS degree in Engineering or Technical Field or equivalent experience
• 2-5 years Medical Device and/or Engineering experience
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to leverage and/or engage others to accomplish projects