Technology Lead | Embedded Software | Medical Devices

Description: POC Diksha

Job Details:
Job title: Senior Quality Analyst (Technology Analyst - US)
Work Location with Zip code: Salt Lake City, UT 84116 (should be in Utah)
Duration of the project: 6 Months
This role requires any travel (Yes/No): NO
Please confirm if this would be onsite from day one OR Initial remote for 2-3 months, and then expect the candidate to work from the office OR 100% Remote: Hybrid
Is this a 100% remote role? NO
Minimum years of experience required: 6-12 yrs
Would you require the candidates to meet you for an in-person interview? Should be okay with both
Education Qualification required: Bachelor s / Masters
Must have skills:
1.Medical devices
2. Medical Device Quality Engineering
3. Manufacturing Quality
4. Root Cause Analysis and CAPA
5. SPC / Process Capability Analysis
6. PFMEA and Control Plans
7. Plastics Manufacturing and Injection Molding
8. Assembly and Labeling Processes
9. FDA and ISO 13485 regulated manufacturing environments
10. capable of operating independently with quality, manufacturing, and operations teams

Detailed Job Description:
1. Medical Device Quality Engineering
2. Manufacturing Quality
3. Root Cause Analysis and CAPA
4. SPC / Process Capability Analysis
5. PFMEA and Control Plans
6. Plastics Manufacturing and Injection Molding
7. Assembly and Labeling Processes
8. FDA and ISO 13485 regulated manufacturing environments

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

Minimum years of experience: 6-12 yrs

Education: Bachelor s / Masters

The top 3 responsibilities would expect the Subcon to shoulder and execute:
FDA and ISO 13485 regulated manufacturing environments
Root Cause Analysis and CAPA
Medical Device Quality Engineering