Quality Engineer II

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in our Structural Heart Division. In Abbott’s Structural Heart (SH) business, our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

As the Quality Engineer II, you'll be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

What You’ll Work On

• Lead the investigation, resolution, and prevention of product and process non‑conformances by applying systematic problem‑solving methodologies, driving effective communication, and implementing robust quality assurances and process controls utilizing the CAPA system to meet or exceed internal and external requirements.
• Expected to have a presence on the manufacturing floor and collaborate with Operators/Group Leads/Supervisors to drive meaningful improvements reinforcing key behaviors and Quality excellence.
• Lead in the completion and maintenance of risk analysis document(s) related to the manufacturing process(es).
• Lead and implement continuous improvement initiatives across product and process areas to enhance performance and support efficient manufacturing operations.
• Support the completion of validation protocols and reports while leading or supporting manufacturing operations through the successful execution of product verification and validation activities.
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
• Assist in the development and execution of streamlined business systems and advanced technology which effectively identify and resolve quality issues.
• 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.
• 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, customers, contractors, and vendors.

Required Qualifications

• 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Strong communication and interpersonal skills.
• 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.
• Advanced computer skills, including statistical/data analysis and report writng skills

Preferred Qualifications

• Prior medical device experience preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
  

Apply Now

• 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

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.