Senior Engineer Quality Systems

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

Benefits offered by this job

Free HIP PPO medical plan

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Dallas, TX is seeking a Senior Engineer Quality Systems to develop and sustain quality systems for the Transfusion Medicine division. You will support commercialized products, new development, manufacturing, and regulatory compliance across multiple functions.

The role requires strong knowledge of FDA, GMP, ISO 13485, and experience leading cross‑functional teams. Excellent problem solving and data‑driven decision making are essential.

Qualifications

• Bachelor’s in electrical or technical field and at least 4 years of experience.
• Strong knowledge of FDA, GMP and ISO 13485 requirements.
• Experience leading cross‑functional project teams and resolving quality issues.

Responsibilities

• Provide Quality System Body of Knowledge support to Division and organization.
• Collect and analyze quality data for monthly metrics and data-driven recommendations.
• Investigate and resolve quality system nonconformances from audits.
• Communicate with management and stakeholders and escalate issues promptly.
• Ensure compliance with ISO 13485, 21CFR 820 and other regulations; support interpretation and improvements.
• Apply problem‑solving methodologies and lead process improvements using quality tools.
• Mentor CAPA engineers and support QMS/EMS initiatives.

Skills

Quality systems knowledge

Problem solving

Cross-functional leadership

Data analysis

Regulatory interpretation

Lean Six Sigma exposure

Education

Bachelor’s in electrical or technical field

Master’s degree (preferred)

Tools

Six Sigma

Lean Manufacturing

Job description

JOB DESCRIPTION:

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

• Masters degree a plus
• 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.
• Prior medical device experience preferred,
• 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.

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 FAMILY:

Operations Quality

DIVISION:

TM Transfusion Medicine

LOCATION:

United States > Irving : LC-02

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

Not Applied

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

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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.