Manager, Design Assurance

Abbott; Minnetonka (MN); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott in Minnetonka, MN seeks a Design Assurance Leader to establish and maintain QA programs ensuring product quality and regulatory compliance across global medical devices.

You will lead the design Quality Engineering team, drive risk management, DFMEA/Control Plan, and collaborate with cross-functional groups to deliver robust quality systems and cost-effective improvements.

Qualifications

• Associate degree (± 13 years).
• Minimum 7 years of quality engineering experience.
• Experience leading design quality teams.

Responsibilities

• Provide design quality engineering leadership in support of medical device development.
• Manage activities of the design Quality Engineering team.
• Identify opportunities to ensure compliance with internal and international quality regulations.
• Drive risk reduction, cost improvement and budgetary responsibility.
• Define and implement critical parameters for design control and related systems.
• Lead cross-functional teams to complete quality initiatives.
• Communicate proactively with senior management and peers.

Skills

Quality leadership

Six Sigma

Lean

Risk management

Cross-functional leadership

Education

Associate degree

Tools

dfMEA

Control Plan

Job description

Abbott 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 – $198,700.00

In 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 environment

Abbott 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.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf