Sr. CAPA Quality Engineer

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Sr. CAPA Quality Engineer

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

The Sr. CAPA Quality Engineer will be responsible for facilitating, executing and working to improve the CAPA process. This position will be located out of our Alameda, CA offices.

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

• B.S. in Engineering, Healthcare or Science field or equivalent combination of education and work experience.
• Masters degree preferred
• Minimum 6 yrs of experience in CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.

Preferred Qualifications

• 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.
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