Senior quality systems consultant capa - medical device #8161

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

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

What you'll do

The purpose of this engagement is to support one of ECI’s client's team in CAPA execution/management and Complaints handling activities. 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
• Support the project team in the review, investigation, and completion of complaint records.

What you will bring

Minimum of 5+ years direct experience in medical device industry

Education: Bachelor’s Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is required

Experience executing CAPA activities and complaints

Demonstrate Strengths in - Identifying creative and efficient solutions to engineering challenges, Translating customer requirements into workable product ideas and solutions. Good analytical and problem-solving skills. Broad and in-depth regulatory knowledge in medical device (Class II and III medical devices)

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.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.