Manager, Design Assurance

Abbott Laboratories; Minnetonka, Northern (MN, KY); Hybrid; USD 99,000 - 199,000; Full time

Job summary

Abbott Laboratories in Minnetonka, MN seeks a Manager, Design Assurance to lead the design quality engineering team supporting medical device development. You will establish and maintain QA programs, policies and controls to ensure products meet regulatory standards.

The role emphasizes risk management, compliance with US QMSR and ISO 13485, and driving improvements through Six Sigma and Lean. You will mentor engineers, collaborate across functions, and ensure timely product realization.

Qualifications

• Minimum 7 years of experience in design quality or related fields.
• Experience leading Quality Engineers and Technicians.
• Familiarity with US QMSR and ISO 13485.
• Strong problem-solving using Six Sigma/Lean.

Responsibilities

• Provide design quality engineering leadership in medical device development.
• Lead the design Quality Engineering team and manage resources.
• Identify opportunities to assure compliance with internal and international regulations.
• Develop risk management processes across product realization.

Skills

Quality leadership

Education

Associates Degree

Job description

## Manager, Design AssuranceApply: United States - Minnesota - Minnetonka: Full time: Posted Today: 31161615Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.## **JOB DESCRIPTION:****Main Purpose of the Role**This position is responsible for providing design assurance leadership for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.**MAIN RESPONSIBILITIES*** Provide design quality engineering leadership in direct support of medical device development, including: Management and development of Quality Engineers and Technicians, and Manage the activities of the design Quality Engineering team.* Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.* Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US QMSR, ISO 13485, etc.* Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.* Define and implement critical parameter for design control and related systems throughout the product lines.* Provide influential peer leadership with international partner site to drive proactive quality improvements.* Identify Quality Initiatives and lead cross-functional teams to complete them.* Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.* Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.* Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.* Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.* Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.* Manage the activities of the Pre-Production Quality Engineering team for new product introduction and sustaining activities* May direct the development; implementation and maintenance of the risk management process in the Quality System across product realization by providing strategic and tactical direction.* May determine the changes; improvements and investments needed to support the risk management process in the Quality System and business driven objectives and to leverage new and evolving regulatory guidance.* May develop best practices to aid in the implementation of risk management requirements. May provide guidance to product teams regarding risk identification; assessment; control and communication.* May maintain the dFMEA and Control Plan templates as well as the Best Practice documents.**QUALIFICATIONS****Education**Associates Degree (± 13 years)**Experience / Background**Minimum 7 years**The base pay for this position is**$99,300.00 – $198,700.00In specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Engineering## **DIVISION:**CRM Cardiac Rhythm Management## **LOCATION:**United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**No## **MEDICAL SURVEILLANCE:**Yes## **SIGNIFICANT WORK ACTIVITIES:**Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environmentAbbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO\\_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\\_Spanish.pdf