DescriptionAbout the roleAs 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 doThe 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)
