Director, Quality Engineering

1 month ago

St Paul, United States Abbott Laboratories Full time

The Opportunity

This position works out of our St. Paul, Tech Center, MN location in the Electrophysiology (EP) business In Abbottâs Electrophysiology (EP) business, weâre advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

WHAT YOUâLL DO 

We are recruiting for a Director, Quality Engineering located in St. Paul, MN at our Tech Center location. This position will support Abbottâs Capital equipment manufacturing for the Electrophysiology Division.   As Director, Quality Engineering, this role will be responsible to foster a culture of cross functional alignment and compliant problem solving. This role is responsible for developing strategies that result in strong supplier relations and  streamlined Production and Process Controls while partnering with the development team to incorporate improvements into future product designs.  You will be responsible for ensuring Abbott provides world-class devices conforming to established requirements and specifications, built following validated processes to meet our customer needs.  

The Director, Quality Engineering is the site-level Quality Management representative, who will champion the manufacturing quality system requirements and ensure they are effectively established and maintained as well as reports on the performance of the quality system to management with executive responsibility.    

Job Duties:

  • Provides overall leadership for Quality policies, approaches, design controls, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems.
  • Oversee the development, implementation, improvement and monitoring of quality processes and procedures to ensure that a device conforms to its specifications.
  • Develop and oversee Supplier Quality activities to effectively manage vendor relations while challenging improved performance and reducing risk.  
  • Identify and implement strategies for more effective/efficient P&PC in the future
  • Understand and support the Post market surveillance activities over the course of the products lifetime.  Monitoring improvements and changes throughout.
  • Serves as the primary site Management Representative for external regulatory inspections and audits.
  • Be an effective member of the cross-functional Director organization to foster a culture of continuous quality compliance, cost, and predictive measures improvements.
  • Hire and retain` a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

EDUCATION AND EXPERIENCE YOUâLL BRING 

Required 

  • Bachelorâs degree in Engineering or equivalent
  • Minimum 10 years of progressive work experience in medical device or high technology industries. Minimum 5 years prior management experience.
  • Knowledge of electronics assembly required, familiarity of test systems a plus.
  • Demonstrated ability to understand/ familiarity with applicable FDA and TUV regulations, and other relevant clinical/regulatory requirements. Class III or II medical device background in a Quality Leadership role. Quality System Regulations knowledge (ISO 9001, ISO 13485).
  • Demonstrated ability to create relationships, influence and move critical projects forward in alignment with key stakeholders.
  • Experience working in a regulated environment required: GMPs, GLP's and GCP's.
  • Proven project management skills; analytical and highly developed problem solving skills.
  • Strong interpersonal skills. Strong leadership skills with demonstrated ability to create momentum and deliver excellent results highly desired. Strong written and oral communication and negotiations skills.
  • Highly developed problem-solving skills. Top performer in managing multiple tasks and priorities.
  • Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies. Experience working in a broader enterprise/cross division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. 
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to travel, including internationally.

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

  • Training and career development, with onboarding programs for new employees and tuition assistance  
  • Financial security through competitive compensation, incentives, and retirement plans  
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs 
  • Paid time off  
  • 401(k) retirement savings with a generous company match 
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:⯠www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. 



The base pay for this position is $143,300.00 â $286,700.00. In specific locations, the pay range may vary from the range posted.

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