Sr. Development Quality Engineer

Abbott; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement savings plan

Tuition reimbursement

Education benefit

Job summary

Abbott is a global healthcare leader seeking a Quality Engineering professional to develop and maintain quality engineering methodologies across new product development, verification, validation, and manufacturing. The role focuses on establishing process controls, leading teams, and ensuring compliance with FDA, GMP, ISO 13485, and ISO 14971, while driving continuous improvement and risk management.

You will collaborate with design engineering, microbiology, and regulatory affairs, mentoring

Qualifications

• Minimum 5 years of Quality, Design Quality, Reliability, Electrical Engineering, or related medical device experience.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971, design controls, and risk management principles.
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including leading multi-departmental project teams.
• Advanced computer skills, including statistical/data analysis and report writing.

Responsibilities

• Identify and implement effective process control systems for product development, verification, validation, and manufacturing.
• Lead, coach, and mentor personnel.
• Develop and execute streamlined business systems to identify and resolve design and quality issues.
• Apply problem-solving methodologies to resolve design, testing, and quality issues.
• Design and conduct experiments for performance, reliability, safety, and verification activities.
• Document experiment plans and results with protocols, test execution, statistics, and reports.
• Lead process control and monitoring of CTQ parameters and specifications.
• Lead product and process improvement methodologies (Six Sigma, Lean).
• Investigate, resolve, and prevent nonconformances including field issues.
• Support quality disciplines in cross-functional teams and governance.
• Partner with design engineering to plan, review, and approve verification/validation activities.
• Provide independent quality oversight for testing to international/regulatory standards.
• Serve as SME for CRM testing including implantable pulse generators and related systems.
• Collaborate with microbiology on environmental monitoring and regulations.
• Support Divisional QMS/EMS initiatives and other regulatory requirements.
• Performs other related duties as assigned.

Skills

Quality engineering

Leadership

Statistical analysis

Design controls

Project management

GMP/ISO knowledge

Medical device experience

Education

Bachelor's Degree in Engineering or Technical Field

Equivalent combination of education and work experience

Tools

Quality tools

Regulatory standards knowledge

Job description

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 115,000 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 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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.

MAIN PURPOSE OF ROLE

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, design verification and validation, manufacturing, or system/services support.

Main Responsibilities

• Identify and implement effective process control systems to support the development, verification, validation qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Lead, coach, and mentor non-exempt and entry level exempt personnel
• Assist in the development and execution of streamlined business systems which effectively identify and resolve design and quality issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving complex design, testing, and quality issues
• Design and conduct experiments for product performance, reliability, safety, and design verification activities
• Appropriately document experiment plans and results, including protocol writing, standards-based test execution, statistical analyses, 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, process and design nonconformances, including field performance and complaint investigations as applicable
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
• ead in the completion and maintenance of risk analysis, ensuring alignment between identified risks, risk controls, and verification evidence.
• Partner with design engineering to plan, review, and approve product verification and validation activities, including electrical, system-level, reliability, and standards-based testing.
• Provide independent quality oversight of testing conducted to applicable international and regulatory standards (e.g., IEC, ISO, ANSI/AAMI, FDA-recognized consensus standards), ensuring test methods, acceptance criteria, and results support product requirements and regulatory compliance.
• Serve as a technical quality subject matter expert for CRM electrical and system-level testing, including implantable pulse generators, leads, programmers, accessories, and supporting systems, as applicable.
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
• 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
• Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications

Education

• Bachelors Degree (± 16 years) in an Engineering or Technical Field (OR)
• An equivalent combination of education and work experience

Experience/Background

• Minimum 5 years of Quality, Design Quality, Reliability, Electrical Engineering, or related medical device experience, including support of product development and design control activities.
• Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971, design controls, and risk management principles.
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience preferred.Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Experience supporting design verification and validation activities, including electrical, system-level, reliability, and standards-based testing.
• Working knowledge of applicable consensus standards and regulatory expectations for medical device testing (e.g., IEC, ISO, ANSI/AAMI, FDA-recognized standards), including test method development, protocol review, and technical assessment of results.
• Experience with Cardiac Rhythm Management (CRM) products and technologies preferred, including implantable pulse generators, leads, programmers, or associated systems.
• 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 leverage and/or engage others to accomplish projects.
• 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.
• Ability to maintain regular and predictable attendance.

Licenses and Certifications

• ASQ CQE or other certifications preferred

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 $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.