Staff CAPA 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.

Staff CAPA Engineer

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

The Opportunity

This position works out of our Alameda, CA location, supporting our Diabetes Care team. This role is responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at Abbott. Reports to the Regulatory Compliance Manager for the business unit.

What You’ll Work On

• Lead, mentor and motivate a team of Quality Engineers as an individual contributor, but a key success factor in mentoring the team overall.
• 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

• Bachelors' in Engineering, Technical Field, Life Science or closely related discipline or an equivalent combination of education and work experience
• Minimum 8 years in Quality or related field experience.
• Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.
• 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 leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to travel up to approximately 20%, including internationally.
  
  

Preferred Qualifications

• Masters' degree preferred
• Prior medical device experience strongly preferred.
• 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 on Twitter @AbbottNews.

The base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.

Salary : $109,300 - $218,500