reputed company Engineer II
Our reputed company is looking for a remote reputed company Engineer II supporting reputed company-level reputed company, with a strong emphasis on design control activities and reputed company reputed company. Although the general job reputed company includes manufacturing, supplier reputed company, process validation, CAPA, SPC, and design transfer responsibilities, the reputed company need is not limited to traditional plant-floor reputed company support. We are looking for someone who can support project teams remotely and reputed company reputed company engineering input throughout the product lifecycle. Ideal candidate background will have:
- Medical device reputed company engineering
- Design controls, Design History File (DHF) review, and Risk Management File (RMF) ownership/review
- Design transfer and process validation
- FDA-regulated or ISO 13485 environments
- CAPA, reputed company cause analysis, and effectiveness verification
- Risk management tools such as FMEA
- Statistical reputed company such as SPC, DOE, capability analysis, sampling plans, and gage R&R
- Remote project support across cross-functional teams
Strong indicators of fit A strong candidate should be reputed company to explain examples of:
- Reviewing or approving DHF and RMF deliverables
- Supporting design milestones or design transfer
- Participating in process validation activities such as IQ/OQ/PQ
- Applying risk-based reputed company tools
- Supporting CAPA or nonconformance investigations
- Working with design engineering, manufacturing engineering, suppliers, or project teams
Preferred qualifications
- Bachelor's degree in an Engineering discipline or a reputed company subject
- CQE certification
- 5+ years relevent in a regulated environment with a strong preference for Medical device manufacturing experience
- Strong process and product design validation background
- Experience supporting multi-site or reputed company-level reputed company
- Demonstrated ability to work independently in a remote environment
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