Manager, Design Quality Assurance

Abbott • St. Paul, MN

1d • Onsite

About The Position

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: Career development with an international company where you can grow the career of which you dream. 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 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. A company recognized as a great place to work in dozens of countries around the world and named 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 as a best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. The Design Quality Assurance Manager has the broad objective of assuring the quality of design from development through manufacture and distribution for assigned products of the division. The successful incumbent will assure product designs provide necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market for new innovations as well as cost effectiveness. The ability to appropriately identify, assess and mitigate risks in the design of products can result in world-wide business interruptions, multi-product/multi-batch recalls and class-action product liability claims. The incumbent will need to provide creative risk mitigation strategies to successfully deliver growth expected throughout the LRP, and attain distribution margin objectives. They may lead a and set expectations against key company and department goals while delivering results.

Requirements

• Bachelors Degree in Chemistry, Biology, Engineering or other technical discipline.
• Minimum 7 years' related work experience.

Nice To Haves

• Medical device industry experience, highly preferred.
• Verification and Validation experience.
• New Product Development (NPD) experience.

Responsibilities

• Responsible for conducting/coordinating design reviews that provide assessment of issues, risks, and resource requirements for all phases of these projects.
• Manage resources to support global projects and product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcome.
• Assure risks are identified, appropriately characterized and managed while meeting established project schedule and cost objectives.
• Assure product/process/package designs and associated documentation comply with applicable Regulations for product distributed in the U.S. and internationally.
• Collaborate with Regulatory Affairs to establish appropriate product filing strategies and provide necessary product documentation for submission.
• Participate in Regulatory Agency inspections (FDA, Ministry of Health, Country health regulatory Agencies) and inquiries associated with product design, change control and complaints.
• Establish and execute policies, procedures, processes and principles to provide robust product designs, assure appropriate evaluation during development and provide necessary change control.
• Collaborate with R&D to design development test plans for new innovations.
• Establish and conduct appropriate start-up testing, reconcile results and release batches for commercial distribution.
• Manage the impact of quality related design criteria on product and operational costs.
• Assure successful and cost-effective scale-up and technology transfer from R&D to commercial manufacture.
• Assure that product performance is monitored via manufacturing non-conformances and complaints. Identify issues, investigate and implement corrective and preventative actions.
• Provide oversight of changes to plant work orders, TPM standard manufacturing plans (SMP), procedures and equipment/processes as they relate to product design, safety, performance, efficacy and testing.
• Evaluate potential acquisitions regarding quality costs, identification/characterization of risks associated with quality/compliance gaps and propose mitigation strategies.
• Hire, train and manage team members to address quality assurance issues across all quality functional areas.

Benefits

• Career development with an international company where you can grow the career of which you dream.
• 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 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.
• A company recognized as a great place to work in dozens of countries around the world and named 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 as a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees