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 109,000 colleagues serve people in more than 160 countries.
About Abbott For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive.
Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.
Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
Our location in St.
Paul, MN or Plymouth, MN or Santa Clara, CA , currently has an opportunity for a Quality Assurance Manager.
WHAT YOU’LL DO We are recruiting for a Quality Assurance Manager to join our team.
In this key leadership role, you will be responsible for building and operating a Quality System within the Regulatory Function.
This is an environment where you can add value while enjoying complexity and variety every day.
You will have three general areas of responsibility: Strategic, including people leadership, training and development Tactical, including day to day execution on KPIs Harmonizing and maintaining key elements of a Quality System including: Regulatory Procedure Harmonization and maintenance as regulations change Managing CAPAs for the Regulatory function.
Establishing and maintaining the Regulatory Training program Responsibilities: Lead cross business unit Regulatory Procedure Harmonization project to align key Regulatory processes across the Medical Device Division Lead cross business unit process and compliance maintenance as regulations change Manage CAPAs for the Regulatory function.
Develop CAPA capabilities and capacity within the Global Regulatory Shared Services staff Establishing and maintaining the Regulatory Training program Establish training plans and training review process for Global Regulatory Shared Services staff EDUCATION AND EXPERIENCE YOU’LL BRING Required:
• Bachelor’s Degree
• 8 years of experience, including a minimum of 5 years experience in regulated industries.
• Quality Systems experience: Document Control, CAPA, Training Systems, etc
• CAPA experience, including working cross-functionally to complete investigations, root cause analysis, action planning, implementation and verifications of effectiveness.
• Process development, People / team leadership experience.
Ability to manage team capacity and capabilities to ensure that demand is met with expected service levels.
Preferred:
• Advanced level degree
• Ability to influence cross-functionally to achieve enterprise objectives.
WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.
We offer: This position is responsible for planning, creating and implementing solutions for regulatory approvals of products.
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.