Senior Engineer Quality Systems

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 150,000; Full time

Job summary

Abbott in Dallas, TX is seeking a Senior Engineer Quality Systems to develop and maintain quality systems across the division, supporting commercialized products, new development, and manufacturing.

You will lead data-driven quality initiatives, collaborate with cross-functional teams, and ensure compliance with FDA regulations and ISO standards, while mentoring junior engineers in a fast-paced environment.

Qualifications

• Bachelor's in electrical or technical field required or equivalent combination of education and work experience.
• Minimum 4 years experience in quality systems.
• Masters degree preferred.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Demonstrated project management and leadership skills across multi-department teams.

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 identified in audits.
• Communicate effectively with all levels of management and stakeholders; escalate issues timely.
• Ensure compliance with ISO 13485, 21CFR 820 and other regulations; support interpretation and gap analysis.
• Lead improvements using Lean Six Sigma and other quality tools to reduce variance and improve processes.
• Mentor CAPA engineers and support cross-functional teams in quality disciplines.

Skills

Leadership

Project management

Problem solving

Communication

Education

Bachelor's in electrical or technical field

Master's degree

Tools

Lean Six Sigma

Six Sigma

Regulatory knowledge (FDA, GMP, ISO 13485)

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.