Sr. Supplier Quality 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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

About Abbott

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The Opportunity

The position of Senior Supplier Quality Engineer is within our Infectious Disease Developed Markets Business located in Scarborough, ME. The Senior Supplier Quality Engineer will be responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.

What You'll Do

• Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms.
• May provide coaching and mentoring for technical team personnel.
• Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
• 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 division 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 Nonconforming Material Reviews.
• Contributes and participates in supplier performance reviews.
• Evaluates and develops Supplied Data Agreement partnerships with suppliers.
• Applies sound engineering analysis and judgment 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).
• 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

Required Qualifications

• Bachelor’s degree in Engineering or Technical Field.
• Minimum 5 years of related experience.
• Engineering experience and demonstrated use of quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Solid communication and interpersonal skills.
• 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.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Strong verbal and written communication

Preferred Qualifications

• Master’s degree preferred
• Prior medical device experience preferred.
• Demonstrated supervisory experience preferred.
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: