What You’ll Work On

• Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements

• Performs re-assessment 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 and documents for closure and filing

• Reviews and approves all supplied product drawings and component quality plans

• Manages the 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 judgment to reduce the need for inspection in accordance with program policies

• Works with Manufacturing engineering to assess and address purchased product issues

• 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

• Contributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms

Required Qualifications

• BS degree in Engineering or Technical Field or equivalent experience

• 5+ years Medical Device and/or Engineering experience

• 3+ years Supplier Development Engineering experience

• Strong technical writing skills

• Experience with root cause identification and problem solving

Preferred Qualifications

• Advanced degree

• Medical device experience

• Engineering experience and demonstrated use of Quality tools/methodologies

• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications are preferred.

• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

• ASQ CQE or other certifications

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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