Senior Quality Engineer

Job Title:Senior Quality Engineer
Location:Salt Lake City, Utah

Client:Biomerics
Experience:6 - 12 years

About Client:

• Biomerics is a well-established MedTech CDMO with approximately12 manufacturing facilities.
• They operate across bothPlastics andMetals manufacturing divisions.
• The immediate requirement is focused on theirUtah Plastics facility.

Immediate Requirement -Biomerics/Stacey is looking for2 Senior Quality Engineers onsite in Utah. The focus is on:

• Quality Assurance
• Root Cause Analysis
• CAPA
• Process Controls and Process Capability Improvements
• Assembly Quality Issues
• Labeling Quality Issues
• Plastics / Molding-related Quality Challenges
• Defect Prevention and Recurrence Reduction

Current Environment -Stacey shared that much of their Root Cause Analysis and Preventive Action process remains manual and paper-based. They currently useMinitab for statistical analysis and investigations and operate within anISO 13485-driven quality environment. The expectation is for engineers who can go beyond investigations and help drive sustainable preventive actions, stronger process controls, and quality improvements.

Profile Expectations -Please prioritize candidates with experience in:

• Medical Device Quality Engineering
• Manufacturing Quality
• Root Cause Analysis and CAPA
• SPC / Process Capability Analysis
• PFMEA and Control Plans
• Plastics Manufacturing and Injection Molding
• Assembly and Labeling Processes
• FDA and ISO 13485 regulated manufacturing environments

The customer is specifically looking forsenior-level engineers capable of operating independently with quality, manufacturing, and operations teams.