Quality Engineer II
Abbott · Minnetonka, MN
- On site
- Full-time
- $90,000 / year
- Minnetonka, MN
Job highlights
- Support product manufacturing and quality in medical devices.
- Ensure compliance with Quality Management System.
- Collaborate with cross-functional teams for success.
- Implement process controls and CAPA systems.
- Resolve quality issues and drive improvements.
About the role
Quality Engineer II
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 115,000 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.
- 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.
Key skills/competency
- Quality Engineering
- Medical Device Manufacturing
- Process Improvement
- CAPA Systems
- Risk Management
- Regulatory Compliance (FDA, ISO 13485)
- Problem Solving
- Six Sigma
- Lean Manufacturing
- Cross-functional Collaboration
Skills & topics
- Quality Engineer
- Medical Device
- Electrophysiology
- Abbott
- Process Control
- CAPA
- Risk Management
- FDA
- ISO 13485
- GMP
- Six Sigma
- Lean Manufacturing
- Engineering
How to get hired
- Tailor your resume: Highlight your engineering background, quality tools experience, and knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- Showcase relevant experience: Emphasize any prior medical device experience and CAPA ownership.
- Demonstrate collaboration skills: Provide examples of working effectively in matrixed and team environments.
- Prepare for technical questions: Be ready to discuss your understanding of quality methodologies and regulatory requirements.
- Express enthusiasm for Abbott's mission: Connect your desire to help people live more fully to the company's goals.
Technical preparation
Master FDA, GMP, ISO 13485, and ISO 14971 standards.,Practice using quality tools and methodologies.,Familiarize yourself with Six Sigma and Lean principles.,Prepare to discuss risk analysis and CAPA systems.
Behavioral questions
Describe a complex quality issue you resolved.,How do you collaborate with cross-functional teams?,Share an experience improving a manufacturing process.,How do you manage multiple priorities and deadlines?
Frequently asked questions
- What are the primary responsibilities of a Quality Engineer II at Abbott's Electrophysiology division?
- The Quality Engineer II at Abbott's Electrophysiology division is responsible for supporting the sustainability of commercially released products, ensuring manufacturing processes meet production schedules, and enhancing productivity and product quality. This role also ensures product conformity to Abbott's Quality Management System and maintains strong collaborative partnerships with cross-functional teams to protect patient safety and meet business needs.
- What qualifications are essential for the Quality Engineer II position at Abbott?
- Essential qualifications include a Bachelor's Degree in engineering or a technical field (or equivalent experience), 2-5 years of engineering experience with demonstrated use of quality tools/methodologies, and detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Strong communication, multitasking, prioritization, and organizational skills are also required.
- Does Abbott offer opportunities for career growth and development for a Quality Engineer II?
- Yes, Abbott emphasizes career development within its international company structure, allowing employees to grow the career they dream of. They also offer benefits like tuition reimbursement and education assistance, supporting continuous learning and advancement.
- What is the typical work environment for a Quality Engineer II at Abbott?
- The role is based in Minnetonka, MN, and requires the ability to work in a highly matrixed and geographically diverse business environment. You'll work within a team and as an individual contributor in a fast-paced, changing environment, maintaining positive and cooperative communications.
- What are the preferred qualifications for this Quality Engineer role at Abbott?
- Preferred qualifications include prior medical device experience and experience as a CAPA owner or a key cross-functional team member leading a CAPA. These experiences would provide a strong foundation for the responsibilities of this role.
- How does Abbott support employee well-being and financial health for a Quality Engineer II?
- Abbott offers comprehensive benefits, including potential qualification for free medical coverage, an excellent retirement savings plan with high employer contribution, and programs like Freedom 2 Save for student debt and FreeU for bachelor's degrees, supporting employees' overall well-being and financial health.