Staff CAPA Engineer

Abbott Diabetes Care Opportunity

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.

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.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the student debt program, and education benefit
• 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

Join us at Abbott Diabetes Care (ADC) in our mission to help individuals with diabetes lead active, fulfilling lives. We're focused on helping people manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decision ADC is responsible for the development and launch of new digital products based on the FreeStyle 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. The position will be responsible for leading and strategizing CAPA projects through its entire life cycle, and mentor quality engineers. The position will help bring new insights to effectively strategize and implement continuous process improvements that aid in improving the CAPA program.

This is a 5 days/week onsite opportunity based out of Alameda, CA.

What You'll Work On

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.

Required Qualifications

B.S. in Engineering, Technical Field, Life Science or closely related discipline. Equivalent combination of education and work experience will be accepted. Masters degree preferred. Minimum 8 years in Quality or related field experience. Previous 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. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 20%, including internationally.