Quality Engineer II

Posted 28 June 2024
Job type Permanent
Contact NameCameron Cyker

Job description


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.