Production Engineer, Medical Devices
Location : Caldwell NJ US 07006
Job Type : Temp/Contract
Reference Code : 20360-BZ1
Compensation : open - 35-40/h
Start Date : 11/02/2020
Hours : Full Time
Required Years of Experience : 2
Required Education : BS Biomedical, Mechanical or Manufacturing Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a Production Engineer for medical device manufacturing.
- Responsible for remediation activities such as reviewing production procedures, addressing deficiencies in documentation, and other improvements related to compliance issues.
- Review production procedures, address deficiencies in documentation, and implement documentation changes as needed.
- Documentation includes engineering specifications, engineering change notices (ECNs), manufacturing procedures, equipment registrations and other documentation.
- Initiate Change Notices to document changes being implemented.
- Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (as applicable to the job function).
Required Qualifications :
- BS Biomedical, Mechanical or Manufacturing Engineering
- Minimum 2-4 years of related experience with medical device manufacturing.
- General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
- Experience with process and equipment validation and qualification.
- Computer skills including, but not limited to: Microsoft Windows, Word, Excel.
- Basic understanding of statistical analysis.
Contact: Bill Zukowsky