Senior Quality Engineer

Abbott Laboratories hiring for Senior Quality Engineer jobs in Roseville, MN, US

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 114,000 colleagues serve people in more than 160 countries.

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 Roseville, 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 Sr. Quality Engineer, you’ll be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within distribution.

What You’ll Work On

• Identify and implement effective process control systems to support the development, qualification, and on-going distribution 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

• Lead, coach, and mentor non-exempt and entry level exempt personnel

• 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

• Appropriately develop and document Quality plans and reports

• 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

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) 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, customers, contractors, and vendors

• Performs other related duties and responsibilities, on occasion, as assigned

Required Qualifications

• BS degree in Engineering or Technical Field or equivalent experience

• 5+ years’ experience with engineering or medical devices

• Engineering experience and demonstrated use of Quality tools/methodologies

• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

• Solid communication and interpersonal skills

• Advanced computer skills, including statistical/data analysis and report writing skills

• 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

• Ability to leverage and/or engage others to accomplish projects

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Preferred Qualifications

• Advance degree

• Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

• Prior medical device experience

• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

• ASQ CQE or other certifications

• SAP system experience

• Distribution experience

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.