Director Sqa Jobs in Minnesota (NOW HIRING)

Working at Abbott

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

• Career development with an international companywhere you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.

• An excellent retirement savings plan withahigh employer contribution

• Tuition reimbursement,theFreedom 2 Savestudent debt program,andFreeUeducation benefit- an affordable and convenient path to getting a bachelor's degree.

• A company recognized asa great placeto work in dozens of countriesworldwideandnamed one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well asthebest place to work for diversity, working mothers, female executives, and scientists.

The Opportunity:

This position worksout ofour New Brighton, MN locationin the SH Division.

Structural Heart Business Mission:Why We Exist

Our business purpose is to restore health and improve quality of lifeby designing and providing device and management solutions for treatingstructural 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 supplierselection, 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 andmaintainthe 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, andmaintainSupplier Quality Agreements (SQAs) and othersupplierquality-related contractual documents.

• Ensure the effectiveness and continuous improvement of the Supplier Quality Assurance (SQA) Quality Management System.

• Partner cross-functionallywith Engineering, Operations, Manufacturing, Regulatory Affairs, and Quality teams to resolve supplier-related quality issues and support businessobjectives.

• Support design control activities and provide supplier quality oversight throughout product development and lifecycle management.

• Review and approve supplier and process changes, ensuringappropriate riskassessments 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 25% (including international travel) to support supplier audits, assessments, business reviews, and quality improvement activities.

Qualifications:

• Bachelor'sDegree 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 organizationalobjectives.

• 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.

• Proficiencywith 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 toestablishgoals, 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.

• 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)stronglypreferred.

• Certified Quality Auditor (CQA), Lead Auditor, or related quality certification is a plus but notrequired.

Apply Now

Learn more about ourhealth and wellnessbenefits, which provide the security to help you and your familylivefull lives:www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company thatcan help youbuild your futureand live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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