Senior Quality Engineer
4 weeks ago
Introduction
We are working with a catheter manufacturer seeking a
Senior Quality Engineer
to join their team out of Greater Boston. You will be responsible for the entire supply quality management process as well as leading CAPA initiatives for new and sustained products.
This role will offer you
Working with next-generation, class III technology.
Hybrid work schedule (4 days onsite/1 day from home).
Ownership of quality processes with upwards mobility.
You will be responsible for
Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Lead CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Provide leadership and oversight for Supplier Qualifications process.
Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies.
You will bring the following
5+ years in a relevant position + BS
or
8 years of experience.
Experience in regulated environments, including ISO 13485, FDA 21 CFR 820, ISO 14971, ISO 14975.
Preferred: ASQ Certification, catheter experience, statistical tools & programs.
Please apply below for consideration
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