Quality Engineer II
JOB DESCRIPTION:
Quality Engineer II
Working at Abbott
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 you dream of.
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.
The Opportunity
This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re 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.
As the Quality Engineer II, you’ll support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
What You’ll Work On
Identify and implement effective process control systems to support the qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Work with cross functional teams to design and conduct experiments for process optimization and/or improvement.
Appropriately document experiment plans and results, including protocol writing and reports
Lead process control and monitoring of CTQ parameters and specifications.
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Lead the investigation, resolution and prevention of product and process non-conformances.
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Lead in the completion and maintenance of risk analysis.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees.
Required Qualifications
Bachelor’s Degree in engineering or Technical Field or an equivalent combination of education and work experience
2-5 years Engineering experience and demonstrated use of quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes, and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Preferred Qualifications
Prior medical device experience preferred.
CAPA owner or a key cross-functional team member leading a CAPA.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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
$61,300.00 - $122,700.00In specific locations, the pay range may vary from the range posted.