Title: Senior Supplier Quality Engineer
Location: MA or MN or CO (3 4 days onsite weekly)
Duration: 24 month contract
Hours Per Week: 40
Start Date: ASAP
Role Overview:
This team will support a newly acquired medical device operation through a major production ramp up. The work is highly hands on, partnering directly with suppliers to resolve quality issues such as scrap, yield challenges, and component level defects. Early months will focus on learning the new Quality Management System, then transitioning into supplier support, root cause analysis, and risk assessments. This will also require developing and executing supplier and product stabilization plans for high risk or single source suppliers. The role combines engineering work on the manufacturing floor with quality/compliance tasks such as audits and updates to quality agreements. Other tasks include providing quality oversight of production/process change requests from suppliers as well as conducting investigations of defects to determine if they are supplier caused and implement corrections. Candidates must be confident working independently and engaging with key supplier stakeholders.
1. Injection Molding & Validation of plastic moulding equipment
2. Medical device experience mandatory
3. Thermal pressure process
4. Titles can be SQE, QE, Product development or Product engineers
Required Skills:
- 5+ years in supplier quality, product quality, or manufacturing engineering with hands on experience
- Strong background in processes such as extrusion, injection molding, sheet metal, or catheter/console manufacturing
- Ability to lead technical discussions and independently drive supplier issue resolution
- SCARs
- Process Validation
Nice to Have:
- ISO 13485 auditing experience (lead auditor preferred)
- Prior experience in fast paced startup or acquisition integration environments
- Mechanical or electrical engineering background
Education: Mechanical or Electrical Engineering preferred