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Quality Engineer II

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 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 II, you’ll have the chance to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system. We need you to be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success by protecting patient safety and meeting business needs. You will be involved in nonconformance and complaint investigation management, including root cause problem solving and providing event information to our various business partners (e.g. Regulatory, Quality Engineering).  

What You’ll Work On

  • Follows all regulations and standards for quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Abbott engineering standards, and other governance areas as applicable.
  • Implements and maintains the effectiveness of the Quality System.
  • Identifies areas of risk with respect to compliance to internal and external requirements.
  • Completes Non-conformance, CAPA, and complaint investigations and offers multiple solutions to issues with clear advantages and disadvantages.
  • Influences key partners to develop and maintain QA procedures, forms, and systems.
  • Leads meetings and communications for QA system information, concerns, and updates.
  • Help drive standard methodologies for data trending and tracking and identification of manufacturing related complaints in alignment with Abbott goals.
  • Follows 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

  • Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
  • 2-5 years technical experience
  • Previous Quality assurance/engineering experience and use of Quality tools/methodologies
  • Good communication and interpersonal skills
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Ability to work within a team and as an individual contributor in a dynamic, changing environment.
  • Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Excellent organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

  • Detailed knowledge of FDA, GMP, and ISO 13485
  • ASQ CQT, CQE, CQA certification
  • Six Sigma root cause analysis/problem solving training and experience

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 and @AbbottGlobal.



The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.

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What You Should Know About Quality Engineer II, Abbott

Are you ready to take your career to the next level as a Quality Engineer II at Abbott in Plymouth, Minnesota? Here, we’re committed to making a difference in the treatment of heart disease with groundbreaking technologies, and we need talented individuals like you to help us maintain quality standards. In this role, you’ll work closely with multi-functional teams to ensure that our products and processes meet the highest quality criteria. You'll be involved in rigorous nonconformance and complaint investigations, employing your problem-solving skills to identify root causes and provide solutions. With a strong emphasis on collaboration and communication, you'll facilitate quality assurance meetings and drive best practices for data analysis and complaint resolution. Our commitment to your growth is unwavering; from career development opportunities to tuition reimbursement programs, we’ll support your journey every step of the way. By joining Abbott, you’ll not only get to work in a dynamic environment that celebrates diversity but also be part of a company recognized as one of the best places to work in multiple categories. With competitive pay and fantastic benefits, including the potential for free medical coverage, a solid retirement plan, and educational opportunities, Abbott is where your skills can truly shine. If you're looking to impact health and wellness while achieving your career aspirations, look no further than the Quality Engineer II position at Abbott.

Frequently Asked Questions (FAQs) for Quality Engineer II Role at Abbott
What are the responsibilities of a Quality Engineer II at Abbott?

As a Quality Engineer II at Abbott, your primary responsibilities will include ensuring that products, processes, and quality records comply with industry standards and internal protocols. You’ll play a pivotal role in nonconformance and complaint investigations, leading teams to identify root causes and propose effective solutions. Moreover, you will collaborate with various stakeholders to maintain the effectiveness of the Quality System, ensuring the safety and efficacy of our medical technologies used in treating heart disease.

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What qualifications are needed to apply for the Quality Engineer II position at Abbott?

To be considered for the Quality Engineer II position at Abbott, applicants should possess a Bachelor’s degree in Engineering or a related technical field; an advanced degree is preferred. You should have 2-5 years of technical experience, specifically in quality assurance or engineering roles. Familiarity with FDA regulations, GMP, ISO 13485 standards, and quality management tools are crucial, alongside strong communication and analytical skills.

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What is the pay range for the Quality Engineer II position at Abbott?

The base pay for the Quality Engineer II position at Abbott ranges from $60,000.00 to $120,000.00. However, specific compensation may vary based on location and experience, and the company is known for offering competitive benefits that enhance employee satisfaction and well-being.

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What career development opportunities does Abbott provide to Quality Engineers?

Abbott is committed to fostering your career growth, especially in the Quality Engineer II role. You’ll have access to comprehensive career development programs, including tuition reimbursement and educational benefits through the FreeU program, allowing you to pursue further education conveniently. Abbott supports your aspirations to build a fulfilling career with tools and resources tailored to help you achieve your goals.

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How does Abbott ensure a positive work environment for Quality Engineers?

Abbott is recognized as one of the best places to work for diversity, equity, and inclusion. The company actively promotes a collaborative and supportive environment, encouraging Quality Engineers to communicate openly and engage with various departments. Regular team meetings and initiatives focused on employee well-being ensure that team members feel valued and contribute to Abbott’s mission of improving global health.

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Common Interview Questions for Quality Engineer II
Can you describe a challenging quality issue you encountered in a previous role?

When answering this question, it's effective to use the STAR method (Situation, Task, Action, Result) to describe the issue succinctly. Highlight the specific challenges you faced, the steps you took to resolve the issue, and explain how your actions led to a positive outcome. Emphasizing your problem-solving skills and collaboration with multi-functional teams will demonstrate your competence as a Quality Engineer II.

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How do you prioritize tasks in a fast-paced quality environment?

To effectively answer this question, share your approach to prioritization, which may include assessing project deadlines, evaluating risks, and communicating with stakeholders. Mentioning tools or methods you use to organize tasks can add depth to your response. Communicate the importance of being adaptable to manage competing priorities, all while ensuring compliance with quality standards.

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What quality assurance tools and methodologies are you familiar with?

In this case, discuss specific quality assurance tools you have experience with, such as Six Sigma, CAPA, and statistical analysis methods. Elucidate any certifications you may possess, like ASQ certifications, and explain how you've used these tools to improve quality processes. Connecting these methodologies to tangible improvements in previous roles will strengthen your response.

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How do you stay updated on quality regulations, such as FDA and ISO standards?

This question is an opportunity to showcase your commitment to professional development. Mention specific resources such as industry webinars, subscriptions to quality assurance journals, and participation in professional organizations. Highlight how continuous learning in these areas has positively impacted your past work as a Quality Engineer.

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Can you explain your experience with complaint and nonconformance investigations?

Provide an overview of your methodologies for handling complaints and nonconformance, including your approach to root cause analysis. Sharing a specific example where you successfully managed an investigation will illustrate your expertise and problem-solving capabilities in the Quality Engineer II role.

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Describe how you would influence key stakeholders to adhere to QA practices.

When responding, focus on your communication and interpersonal skills. Give examples of how you've effectively persuaded team members or management to align with quality assurance practices through education, collaboration, or presenting data-driven insights. Highlighting your ability to build rapport and trust will show you can be a strong advocate for quality standards.

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What steps do you take to ensure thorough documentation within a quality system?

Discuss your methodical approach to maintaining quality documentation, emphasizing the importance of accuracy and compliance. Mention specific documentation practices, such as regular reviews, audits, and training sessions you have implemented to ensure all team members understand the quality system. This demonstrates your attention to detail and dedication to upholding quality processes.

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What role does teamwork play in quality assurance?

In your answer, emphasize the collaborative nature of quality assurance. Share examples of how you've worked closely with other departments to ensure quality compliance and how those collaborations have facilitated successful outcomes or improvements. Highlight your belief that quality is a shared responsibility across the organization.

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How would you handle conflicting priorities in your role as a Quality Engineer II?

Explain your strategy for managing conflicting priorities, including effective time management and prioritization skills. You can mention how you'd communicate with supervisors or team members to negotiate timelines and ensure that critical quality standards are met, underscoring your adaptability in a dynamic environment.

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Why do you want to work as a Quality Engineer II at Abbott?

This question is an invitation to express your passion for quality assurance and meaningful work. Share your understanding of Abbott's commitment to advancing healthcare and your eagerness to contribute to this mission. Link your career aspirations to the opportunities at Abbott, emphasizing how the company aligns with your professional goals and values.

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