Sr. Supplier Quality Engineer

About the role

The opportunity is located in New Brighton, MN on the Structural Heart team within Abbott.

Responsibilities

• 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.
• Affords assessments of 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 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.
• Designs and conducts experiments for process optimization and/or improvement.
• Participates or leads 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.

Requirements

• Minimum 5 years of related experience in supply chain, planning, or operations.
• Medical device industry experience preferred.
• Demonstrated supervisory or leadership experience.
• Strong knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with SAP and maintaining master data integrity.
• Solid communication and interpersonal skills.
• Pioneered project management and leadership capabilities.
• Advanced computer skills including data analysis and report writing.
• Experience with Six Sigma, Lean Manufacturing, or other improvement methodologies.

Qualifications

• ASQ CQE or other relevant certifications preferred.
• ISO 13485 auditing experience preferred.
• Experience working in a cross-divisional or enterprise-level business model.
• Ability to thrive in a matrixed and geographically diverse environment.
• Strong team collaboration and individual contributor skills.
• Ability to engage and influence others to accomplish goals.
• Effective communication across multiple organizational levels.
• Willingness to potentially travel 10%, including internationally.

Skills

• Quality Engineering
• Supplier Development
• Manufacturing Engineering
• Process Optimization
• Problem Solving

Benefits

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

Pay

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.