Sr. CAPA Quality Engineer

Sr. CAPA Quality Engineer

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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.

Working 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 the following benefits:

• 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.

Personalized healthcare is the future. Bio‑wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives.

Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the Free Style Libre platform, the world’s #1 continuous glucose monitoring (CGM) solution.

This position will be based out of Abbott Diabetes Care Division in Alameda, CA and the individual will be expected to be onsite Mon‑Fri. The position will be responsible for driving CAPA projects through its entire life cycle, mentoring lower-level engineers, and strategizing continuous process improvements that aid in improving the CAPA program.

• Lead, mentor and motivate a team of Quality Engineers.
• Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
• Accountable for leadership and oversight of the CAPA system, and associated deliverables.
• Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.
• Lead and/or contribute to continuous improvement initiatives and projects.
• Provide subject matter expertise during audits and inspections.
• Represent CAPA QA in cross‑functional meetings (site and division).
• High proficiency leading meetings and communications for QA system information, concerns, and updates.
• Lead, develop, and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
• Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

• B.S. in Engineering, Technical Field, Life Science or closely related discipline. Equivalent combination of education and work experience will be accepted.
• Minimum 6 years in Quality or related field experience.
• Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.

• Prior medical device experience.
• Masters…