Senior Quality Systems Engineer- CAPA/Complaints Support - Medical Device #8161

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.

As a Senior Quality Systems Engineer, you will support one of ECI’s client's team in CAPA execution and management.

You will work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.

The purpose of this engagement is to support one of ECI’s client's team in CAPA execution and management.

Tasks will include but not limited to:

• Manage existing CAPA records Gather required evidence and supporting documentation to support CAPA execution Support updates to ECI’s client processes or other documentation as directed Drive completion of CAPA activities within prescribed timelines Provide guidance to the team members on industry best practices for successful CAPA execution Prepare CAPA metrics (as required) to provide updates on the status of CAPAs and demonstrate the effectiveness of the CAPA process