Job Description :
Pay Range $54.18hr - $59.18hr
Responsibilities :
- Work with new product development teams (Implants, Delivery Systems and Accessories) to help them efficiently navigate the client’s Quality System in order to build quality system test samples and human use products according to project schedules.
- Identify and ensure implementation of opportunities to optimize / improve manufacturing and inspection processes.
- Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews).
- Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations).
- Develop / drive improvements for inspection test methods.
- Lead test method validation activities for in-process inspections.
- Facilitate and oversee Material Review Board to dispose of potentially non-conforming human use products.
- Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements.
Education and Experience :
- Bachelor's degree in engineering required.
- 5-7 years experience required.
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