Senior Engineer Quality Systems

Abbott; Irving (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Dallas, TX, Irving area, seeks a Senior Engineer Quality Systems to develop and maintain quality systems for the Transfusion Medicine division. The role supports commercialization, new product development, and manufacturing while ensuring regulatory compliance with FDA, GMP, and ISO 13485.

The position emphasizes data-driven decision making, LEAN/Six Sigma approaches, and cross-functional leadership across a matrixed environment. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree in electrical or technical field.
• Minimum 4 years experience.
• Knowledge of FDA, GMP, and ISO 13485.
• Experience leading multi-departmental project teams.
• Six Sigma / Lean Manufacturing experience preferred.
• ASQ CQE, CQA certifications preferred.

Responsibilities

• Provide Quality System Body of Knowledge support to Division and organization.
• Collect and analyze quality data for monthly metrics and trends.
• Investigate and resolve quality system nonconformances.
• Communicate with management and stakeholders; escalate issues as needed.
• Ensure compliance with ISO 13485, 21CFR 820 and other regs; lead gap analyses.
• Lead process improvements to enhance product quality and reduce variance.
• Mentor CAPA engineers and support regulatory requirements.

Skills

Project management

Leadership

Analytical skills

Report writing

Communication

Problem solving

Education

Bachelor’s in electrical or technical field

Tools

Six Sigma

Lean Manufacturing

ASQ CQE

CQA

Job description

Location United States - Texas - Irving Category Quality

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.

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 Dallas, TX location in the Transfusion Medicine, Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

The Senior Engineer Quality Systems is responsible for developing and maintaining quality systems and providing quality system support for the division (e.g., commercialized products, new product development, manufacturing, and/or system compliance).

What You’ll Work On

• Provides Quality System Body of Knowledge support to Division and organization.
• Collect and analyze quality data as needed for monthly metrics and data driven recommendations based on trends.
• Investigates, and resolves quality system nonconformance’s (defined during internal and/or external audits.
• Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
• Ensures compliance with ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• As appropriate, utilizes Lean Six Sigma, and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.
• Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
• As appropriate, participates in or leads teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member). Mentor lower-level CAPA engineers.
• 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.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Required Qualifications

• Bachelor’s in electrical or technical field, or an equivalent combination of education and work experience.
• Minimum 4 years experience.

Preferred Qualifications

• 4-8 years technical experience.
• Previous Quality experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system related issues in a timely and effective manner.
• Advanced computer skills, including gap analysis and report writing skills.
• Six Sigma certification or Lean Manufacturing experience preferred. ASQ CQE, CQA
• preferred certification.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• 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.
• Ability to travel, including internationally.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

https://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.

The base pay for this position is $78,000.00 - $156,000.00. In specific locations, the pay range may vary from the range posted.

Job Id 31165170 Location United States - Texas - Irving Medical surveillance Not Applicable Division TM Transfusion Medicine Travel Yes, 10 % of the Time Additional Location Significant work activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day); Keyboard use (greater or equal to 50% of the workday); Work requiring repeated bending, stooping, squatting or kneeling

INNOVATIVE BENEFITS

DIVERSITY & INCLUSION

We strive to provide environments where all employees feel welcome and able to bring their full selves to work. To do this we integrate diversity, equity, and inclusion across Abbott.

SUSTAINABILITY FOR OUR FUTURE

At Abbott, sustainability means managing our efforts so we can help the greatest number of people around the world live fuller lives through better health.

WE'RE RECOGNIZED AROUND THE WORLD

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We will notify you about relevant positions, and keep you in mind when we have interesting opportunities.

We provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340 or email [e-mail]. Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, and gender-neutral criteria in compliance with applicable laws and local regulations.