We’re looking for a hands-on Quality / Manufacturing Engineer with strong experience in Class IIb/III medical devices to join a growing and dynamic team. This role is ideal for someone who thrives in regulated environments and enjoys working cross-functionally across production, quality, and suppliers.
Ready to apply Before you do, make sure to read all the details pertaining to this job in the description below.
Key Responsibilities
- Support manufacturing and quality processes for sterile medical devices
- Drive root cause investigations for manufacturing-related issues
- Manage and support CAPA, non-conformances, and complaints
- Work closely with production teams and external suppliers
- Lead and support change control processes
- Contribute to process validation and risk management activities
- Review and update SOPs and work instructions
- Participate in internal and external audits (front & back office)
Essential Requirements
- Experience with Class IIb/III devices
- Strong knowledge of ISO 13485 and 21 CFR 820
- Background working for a legal manufacturer or subcontract manufacturer
- Understanding of:
- QC & GD&T on drawings
- Process risk management & validation
- Experience liaising with suppliers and production teams
- Proven audit experience (internal + external)
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Desirable
- Validation protocol authoring
- Experience setting up new production lines/processes
- Exposure to additive manufacturing
- Engineering background
- Lead auditor training
- Experience in a start-up environment
- Authorship of procedures
If you're looking to make an impact in a high-quality, fast-paced Medtech environment, apply or reach out directly to learn more.