Quality Engineer II

Thornton Tomasetti; California; On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott Laboratories is seeking a Quality Engineer to develop and maintain quality engineering methodologies across new product development, manufacturing, and services. You will lead process control systems, mentor staff, and collaborate across design, microbiology, and manufacturing functions to ensure regulatory compliance and product quality.

The role requires 5+ years of experience in quality engineering, expertise in Six Sigma/Lean, and strong data analysis and communication skills.

Qualifications

• Education: Bachelor's degree in engineering/technical field or equivalent experience.
• Experience: minimum 5 years in quality engineering or related roles.
• Supervisory experience preferred; use of quality tools/methodologies expected.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971 required.
• Strong communication and interpersonal skills are essential.
• Demonstrated project management and leadership abilities across multiple teams.
• Proficient in statistics, data analysis, and report writing.
• Experience with Six Sigma and Lean Manufacturing methodologies.
• ASQ CQE or similar certification preferred.

Responsibilities

• Identify and implement effective process control systems for development, qualification, and manufacturing.
• Lead, coach, and mentor personnel across levels.
• Develop and execute streamlined systems to identify and resolve quality issues.
• Apply systematic problem-solving to prioritize and resolve quality issues.
• Design and conduct experiments for process optimization.
• Document experiment plans and results, including protocols and reports.
• Lead process control and monitoring of CTQ parameters and specs.
• Lead improvement methodologies (Six Sigma, Lean) across products and processes.
• Investigate, resolve, and prevent nonconformances.
• Collaborate with cross-functional teams on quality decisions and practices.
• Contribute to risk analysis and product verification/validation activities.
• Support Quality Management Systems (QMS) and Environmental Management Systems (EMS).
• Prepare SOPs and DWIs for business units and processes.
• Coordinate with Distribution Centers on quality issues and corrective actions.
• Support process development and new product introduction for externally manufactured items.

Skills

Quality tools/methodologies

Six Sigma

Lean Manufacturing

Project management

Leadership

Statistical analysis

FDA/GMP/ISO knowledge

Communication skills

Teamwork

Problem solving

Education

Bachelor's Degree in Engineering or Technical Field

Tools

Statistical analysis software

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 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 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 THE ROLE

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

MAIN RESPONSIBILITIES

• Identify and implement effective process control systems to support the development, 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 quality issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Design and conduct experiments for process optimization and/or improvement
• Appropriately document experiment plans and results, including protocol writing and reports
• Lead process control and monitoring of CTQ parameters and specifications
• Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
• Lead the investigation, resolution and prevention of product and process nonconformances
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
• Lead in the completion and maintenance of risk analysis
• Work with design engineering in the completion of product verification and validation
• 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.
• Develop, lead and implement Standard Operating Procedure (SOP) and Detailed Work Instruction (DWI) for Business Unit and Process based on existing SOP and DWI
• Manage as primary contact with Distribution Centers regarding discussion of Quality Issue and help coordinate and lead Nonconformance and Corrective Actions for issues
• Support process development and new product introduction for externally manufactured product, component and accessories

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
• Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• 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 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
• ASQ CQE or other certifications preferred

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.

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

Família de Cargo Operations Quality Divisão CRM Cardiac Rhythm Management Localidade United States > Sylmar : 15900 Valley View Court Localidades Adicionais Turno de Trabalho Standard Viagem Yes, 10 % of the Time Vigilância médica Not Applicable Atividades de trabalho significativas 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) Abbott 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.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is an Equal Opportunity Employer, committed to employee diversity.

A Abbott significa o poder da saúde. Por mais de 125 anos, a Abbott tem ajudado as pessoas a alcançar seu potencial — porque uma saúde melhor permite que indivíduos e comunidades vivam melhor. Com uma rede global e diversificada, que serve clientes em mais de 160 países, criamos novas soluções — em todo o espectro da saúde, em todo o mundo, para todas as fases da vida. Seja através da próxima geração de equipamentos de diagnóstico, dispositivos médicos para estilos de vida em transformação, nutrição baseada em ciência, ou novas reformulações, estamos desenvolvendo tecnologias mais inovadoras e revolucionárias na área da saúde para que indivíduos vivam melhor e com mais saúde. Os colaboradores da Abbott vêm trabalhar todos os dias com energia, entusiasmo e comprometimento com o intuito de promover a saúde e o bem-estar de milhões de pessoas. Eles superam os limites para ajudar a gerenciar e tratar alguns dos maiores desafios de saúde da vida. Convidamos você a explorar as oportunidades na Abbott, a ver se seus talentos e aspirações de carreira podem se encaixar com as nossas vagas. A Abbott é uma empresa que oferece oportunidades iguais e acolhe e incentiva a diversidade em nossa força de trabalho.

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