Introduction

We are working with a medical equipment manufacturer seeking a Senior Quality Engineer to join their team. This is with a turnkey medical device CDMO focusing on complex surgical equipment design and manufacturing.

This role will offer you

• Working with class III technology assisting with life-saving surgical procedures.
• Tenured company history of unique product - market frontrunner for product line.
• Annual Bonus + 401(k).

You will be responsible for

• Design, document and implement methods for process control, process improvement, testing and inspection.
• Conduct root cause analysis as needed, utilizing applicable tools to ensure robust solutions or improvements are determined and implemented.
• Facilitate and lead CAPA meetings.
• Lead appropriate advanced product quality planning (APQP) processes within the organization to ensure product and process validation and verification.
• Work with engineering team using past performance data to prevent future occurrences. Utilize tools such as DOE, DFM, FMEAs, GD&T, process capability, 6-sigma designs, etc.

You will bring the following

• 3-5 years in a relevant position + BS in an engineering capacity. Certified Quality Engineer preferred.
• Experience in regulated, relevant environments (FDA 21 CFR Part 820, ISO 13485, ISO 14971, etc.).
• Experience with audits, preferably within an ISO 13485 environment, is preferred.