Brief Description
About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role
Our CAPA Speciates play a critical role in ensuring that our client's products meet the highest standards of quality and safety. This role will be responsible for independently supporting CAPA teams in the compliant execution of CAPA tasks. You will also have the opportunity to promote a culture of continuous improvement by identifying problems, conducting root cause analysis, and implementing corrective and preventive actions.
What You'll Do

• Evaluate CAPA records for compliance to the documented QMS procedures and good CAPA industry practices.
• Mentor quality, operations, engineering, and cross-functional teams on effective CAPA practices.
• Coach CAPA owners through all phases of the CAPA.
• Improve the effectiveness of root cause methodologies (e.g., 5 Whys, Fishbone, Fault Tree, Human Factors).
• Ensure CAPAs are appropriately scoped, timely, and aligned with product and patient risk.
• Drive meaningful effectiveness checks that verify true problem resolution.
• Review CAPAs for inspection readiness, including traceability to design controls, risk management, complaints, and production records.
• Facilitate cross-functional alignment when CAPAs impact design, manufacturing, suppliers, or post-market surveillance.
• Promotes culture of continuous improvement by confirming appropriate implementation of corrections, corrective and preventive actions.
• Complete CAPA tasks as needed to complete activities within assigned timelines.
  

What We Look For

• Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering
• 6+ years of experience in the MedTech industry in Manufacturing, Quality or Engineering preferred Previous experience in quality assurance or quality control within the biotech or medical technology industry
• Knowledge of Quality/Compliance management, Regulations and Standards
• Strong understanding and experience in CAPA management and related areas (deviation management, change control, risk management)
• Demonstrates ability to problem solve and utilize analytical skills
  

ECI is an equal opportunity employer
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.