Quality Engineer I

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. Youll 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 bachelors 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 St. Paul MN location in the Electrophysiology Abbotts Electrophysiology (EP) business were 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 I you will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development sustaining products manufacturing or system/services support.

What Youll Work On:

• Identify and implement effective process control systems to support the development qualification and on-going manufacturing of products to meet or exceed internal and external requirements

• Assist 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

• 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 nonconformances

• 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

• Work with design engineering in the completion of product verification and validation

Required Qualifications

• Bachelors degree in engineering or Technical Field or an equivalent combination of education and work experience

• 0-2 years Engineering experience

• 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

• Experience working in a broader enterprise/cross-division business unit model preferred

• CAPA owner or a key cross-functional team member leading a CAPA project

• Use of quality tools/methodologies. Detailed knowledge of FDA GMP ISO 13485 and ISO 14971

• Risk management post market surveillance and manufacturing analysis

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

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.

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