Quality Engineer I

Thornton Tomasetti; Plymouth (MN); On-site; USD 51,000 - 101,000; Full time

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

Education benefit - FreeU

Job summary

Abbott in Plymouth, MN is seeking a Quality Engineer I to support QA programs that assure product quality and regulatory compliance in the Electrophysiology division.

This role operates in a highly matrixed environment, focusing on CAPA, data analysis, and process improvements while aligning with FDA/ISO requirements.

Qualifications

• Bachelor’s degree in engineering or technical field or equivalent experience.
• 0–2 years engineering experience.
• Ability to work in a highly matrixed and geographically diverse environment.
• Strong verbal and written communications across multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines with attention to detail.

Responsibilities

• Ensure compliance with corporate and divisional policies.
• Lead or support CAPA activities and quality improvements.
• Prepare reports and communicate findings to stakeholders.
• Apply engineering principles to solve problems and support product quality.

Skills

Verbal and written communication

Matrixed environment

Attention to detail

Organizational skills

Education

Bachelor’s degree in engineering or technical field

Job description

Job Description

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION: 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. 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.

Opportunity

This position works out of our Plymouth, 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 I, you will be responsible for supporting and maintaining quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency regulations.

What You’ll Work On

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
• Prepares reports, publishes, and makes presentations to communicate findings.
• Analyzes and solves problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
• Understands and can apply engineering principles theories, concepts, practices, and techniques.
• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company.
• Incorporates business policies and procedures into task completion.
• Cultivates internal and external network of resources to complete tasks.
• Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives.
• Supports project team, determining goals and objectives for the projects.
• Recommends and implements changes to the system as the result of changing regulations and/or business needs.
• Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related crises (e.g. patient injury due to product malfunction).
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• 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

• Bachelor’s 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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Compensation

The base pay for this position is $50,700.00 – $101,300.00 In specific locations, the pay range may vary from the range posted.

Job Family

Operations Quality

Division

EP Electrophysiology

Location

United States > Minnesota > Plymouth : 5050 Nathan Lane N

Additional Locations

• WORK SHIFT: Standard
• TRAVEL: No
• MEDICAL SURVEILLANCE: No
• SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Equal Opportunity and Diversity Statements

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Company Culture

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us

Facebook LinkedIn YouTube Twitter