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Job Details


Senior CAPA Quality Engineer



Full Time

On Site


Alameda, California, United States

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.

About Abbott

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with lifechanging products that provide accurate data to drive better-informed decisions. We’re revolutionizing the
way people monitor their glucose levels with our new sensing technology.

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 [Register to View] student debt program and [Register to View] 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.

The Opportunity
Responsible for facilitating, executing and working to improve the CAPA process.

What You'll Work On

  • Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

  • Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.

  • Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).

  • Independently investigate, gathers data, and perform preliminary analysis.

  • Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.

  • Lead meetings and communications for CAPA updates, information, and concerns.

  • Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.

  • Support team in the delivery and oversight of CAPA training program.

  • Assist in the initiation, processing and completion of CAPA records in the electronic system.

  • Execute and provide on-time completion of Quality Assurance engineering deliverables.

  • Provide support and subject matter expertise during audits and inspections.

  • Lead and/or contribute to continuous improvement initiatives and projects.

  • Mentor lower level CAPA engineers.

  • 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 Degree preferably in the engineering, healthcare, or science fields or an equivalent combination of education and work experience. Master's Degree preferred.

  • Minimum 5 years' work experience.

  • Significant engineering and/or technical operational experience plus demonstrated competence.

  • Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.

  • Prior medical device experience preferred.

  • Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.

  • Solid communication and interpersonal skills.

  • Demonstrated and impactful project management and leadership skills, including the 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.

  • 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 travel approximately 5%, including internationally.

  • ASQ CQT, CQE, CQA certification preferred.

  • Six Sigma root cause analysis/problem solving training and experience preferred.

  • Experience working in a broader enterprise/cross-division business unit model preferred.

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The base pay for this position is $82,100.00 – $164,100.00. In specific locations, the pay range may vary from the range posted.