Sr. Supplier Quality Engineer

Abbott • New Brighton, MN

2d • $78,000 - $156,000 • Onsite

About The Position

This position works out of our Woodridge St. Paul, MN location on our Structural Heart team. The Supplier Development Quality Engineer is responsible for activities related to supplier selection and evaluation, material qualification, supplier performance, and receiving inspection. This role contributes to the development, establishment, and maintenance of supplier quality engineering methodologies, systems, and practices that meet company and regulatory requirements.

Requirements

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

Nice To Haves

• Medical device industry experience preferred.
• 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.

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.
• 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 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.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Designs and conducts experiments for process optimization and/or improvement.
• Participates in or leads teams in supporting Supplier Development Quality program requirements (e.g., represents 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.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed