Abbott

Quality Engineer II

Abbott • $61K — $122K *
Minnetonka, MN 55345In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Reposted Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in engineering or a technical field or equivalent experience
  • 2-5 years of engineering experience with quality tools/methodologies
  • Detailed knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971
  • Ability to thrive in a fast-paced, matrixed, geographic environment
  • Strong verbal and written communication skills across multiple organizational levels
  • Effective multitasking and prioritization abilities
  • Attention to detail and strong organizational skills

Responsibilities

  • Identify and implement effective process control systems for manufacturing
  • Lead the implementation of CAPA systems and process controls
  • Assist in developing streamlined systems to resolve quality issues
  • Apply systematic problem-solving methodologies for quality issues
  • Collaborate with teams for process optimization experiments
  • Document experimental plans, results, and reports
  • Oversee process control and monitoring of critical parameters

Benefits

  • Health and wellness benefits for employees and their families
  • Opportunities for career growth within a diverse company
  • Support for Quality Management Systems and regulatory compliance initiatives
  • Positive and cooperative work environment across all employee levels
Full Job Description
JOB DESCRIPTION:

Quality Engineer II

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.


Required Qualifications
  • Bachelor's Degree in engineering or Technical Field or an equivalent combination of education and work experience
  • 2-5 years Engineering experience and demonstrated use of quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
  • 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.
  • CAPA owner or a key cross-functional team member leading a CAPA.


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.

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.

JOB FAMILY:
Operations Quality

DIVISION:
EP Electrophysiology

LOCATION:
United States > Minnesota > Minnetonka : 14901 DeVeau Place

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

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), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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