Supplier Quality Manager

Abbott • Saint Paul, MN

4d • Onsite

About The Position

This position works out of our New Brighton, MN location in the SH Division. Structural Heart Business Mission: Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. What You'll Work On: Lead and manage a team of 6 Supplier Quality professionals, providing coaching, development, performance management, and strategic direction. Oversee supplier quality assurance activities across a global supplier network, including supplier selection , qualification, audits, performance monitoring, and continuous improvement initiatives. Conduct and coordinate supplier audits, both domestic and international, ensuring compliance with quality system requirements and regulatory standards. Own and maintain the Approved Supplier List (ASL), including supplier qualification, evaluation, and ongoing performance assessments. Drive supplier corrective action activities, including investigation, issuance, and closure of CAPAs and supplier quality exceptions. Manage supplier change notifications and assess the quality impact of supplier and manufacturing process changes. Serve as the quality lead for third-party manufacturing partners, ensuring compliance with quality agreements, performance expectations, and regulatory requirements. Develop, negotiate, and maintain Supplier Quality Agreements (SQAs) and other supplier quality-related contractual documents. Ensure the effectiveness and continuous improvement of the Supplier Quality Assurance (SQA) Quality Management System. Partner cross- functionally with Engineering, Operations, Manufacturing, Regulatory Affairs, and Quality teams to resolve supplier-related quality issues and support business objectives . Support design control activities and provide supplier quality oversight throughout product development and lifecycle management. Review and approve supplier and process changes, ensuring appropriate risk assessments and quality controls are implemented. Monitor supplier quality metrics and performance trends, driving improvement plans where needed to achieve quality, delivery, and compliance objectives. Act as both a strategic leader and hands-on contributor, balancing people management responsibilities with direct execution of critical supplier quality initiatives. Travel approximately 20% (including international travel) to support supplier audits, assessments, business reviews, and quality improvement activities.

Requirements

• Bachelor's Degree in a related field (Engineering Strongly Preferred)
• Minimum 5 years of experience in supplier quality, quality assurance, or a related quality function within an FDA-regulated and/or ISO-certified environment.
• Proven leadership experience managing, developing, and motivating teams to achieve departmental and organizational objectives.
• Strong experience supervising, training, coaching, and evaluating employees, with a demonstrated ability to provide constructive feedback and drive performance improvement.
• Experience managing departmental resources, budgets, and priorities to support business goals.
• Strong written and verbal communication skills, with the ability to effectively communicate across all levels of the organization.
• Proficiency with quality systems, engineering applications, and business software tools used in a regulated manufacturing environment.
• Experience working within cross-functional, highly matrixed organizations and collaborating across multiple business units.
• Ability to build strong partnerships and influence stakeholders in a geographically diverse and global business environment.
• Demonstrated ability to establish goals, drive accountability, and deliver business results through effective leadership and team engagement.
• Strong organizational, planning, and project management skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Proven ability to analyze problems, make sound decisions, and drive effective resolution of supplier quality and operational issues.
• Ability to travel up to 20% domestically and internationally to support supplier audits, assessments, and quality initiatives.

Nice To Haves

• Experience with supplier audits, supplier quality systems, CAPAs, supplier change management, third-party manufacturing oversight, and supplier performance management preferred.
• Experience with Design Controls and Supplier Quality Agreements (SQAs) strongly preferred.
• Certified Quality Auditor (CQA), Lead Auditor, or related quality certification is a plus but not required.

Responsibilities

• Lead and manage a team of 6 Supplier Quality professionals, providing coaching, development, performance management, and strategic direction.
• Oversee supplier quality assurance activities across a global supplier network, including supplier selection, qualification, audits, performance monitoring, and continuous improvement initiatives.
• Conduct and coordinate supplier audits, both domestic and international, ensuring compliance with quality system requirements and regulatory standards.
• Own and maintain the Approved Supplier List (ASL), including supplier qualification, evaluation, and ongoing performance assessments.
• Drive supplier corrective action activities, including investigation, issuance, and closure of CAPAs and supplier quality exceptions.
• Manage supplier change notifications and assess the quality impact of supplier and manufacturing process changes.
• Serve as the quality lead for third-party manufacturing partners, ensuring compliance with quality agreements, performance expectations, and regulatory requirements.
• Develop, negotiate, and maintain Supplier Quality Agreements (SQAs) and other supplier quality-related contractual documents.
• Ensure the effectiveness and continuous improvement of the Supplier Quality Assurance (SQA) Quality Management System.
• Partner cross-functionally with Engineering, Operations, Manufacturing, Regulatory Affairs, and Quality teams to resolve supplier-related quality issues and support business objectives.
• Support design control activities and provide supplier quality oversight throughout product development and lifecycle management.
• Review and approve supplier and process changes, ensuring appropriate risk assessments and quality controls are implemented.
• Monitor supplier quality metrics and performance trends, driving improvement plans where needed to achieve quality, delivery, and compliance objectives.
• Act as both a strategic leader and hands-on contributor, balancing people management responsibilities with direct execution of critical supplier quality initiatives.
• Travel approximately 20% (including international travel) to support supplier audits, assessments, business reviews, and quality improvement activities.

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: Manager