Quality Engineer

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.  

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.  

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO  

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 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 the best place to work for diversity, working mothers, female executives, and scientists.   

The Opportunity   

 The position of Quality Engineer is within our RMDx division based in Carlsbad, CA.   

This position is responsible for executing Quality Engineering methodologies and providing Quality Engineering support within new product development, manufacturing, or system/services support.  

What You’ll Work On  

• Identify, review, and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.  

• Perform Risk Assessments, as required, across functions, including FMEA, change management, and issue investigation/resolution.   

• Lead in the review and/or implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.  

• Assist in the review, development, and execution of streamlined business systems that effectively identify and resolve quality issues.  

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.  

• Appropriately document experiment plans and results, including protocol writing and reports.  

• Lead process control and monitoring of CTQ parameters and specifications.  

• Lead the investigation, resolution, and prevention of product and process non-conformances.  

• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)  

Required Qualifications  

• Bachelor's degree in science, Engineering, or a closely related discipline.  

• 2-5 years of Quality related experience in the relevant medical device/biotech industry.   

• Solid communication and interpersonal skills.   

• Project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues quickly and effectively.   

• Advanced computer skills, including statistical/data analysis and report writing skills. Prior medical device experience is 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 is 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 communication with the ability to effectively communicate at multiple levels in the organization.   

• Multitasks prioritizes and meets deadlines promptly.   

• Strong organizational and follow-up skills, as well as attention to detail.  

Preferred  

• Americal Society of Quality (ASQ) and Certified Quality Engineer (CQE) or other certifications preferred.  

• Previous Quality engineering-related experience.  

• Previous experience with Validation, Change management, and Non-Conformance/CAPA.  

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.  

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 Twitter @AbbottNews.