AL
Technology Lead | Embedded Software | Medical Devices
Artech LLC
- 🇨🇦 Canada | 🇺🇸 United States
- Remote
- Staff / Principal
- 14 hours ago
- CAPA
- SPC
- PFMEA
14 hours ago
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
Technology Lead | Embedded Software | Medical Devices · Artech LLC