Location : West Caldwell NJ US 07006
Job Type : Temp/Contract
Reference Code : 19885-BZ1
Compensation : open - 38-42/h
Start Date : 07/15/2019
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- One year contract position for a Production Engineer for remediation activities such as performing equipment qualifications, addressing deficiencies in documentation, and other improvements related to compliance issues.
- Write and execute qualification protocols, such as installation or process qualifications. Compile and analyze protocol test data.
- Implement documentation changes as needed. (Engineering specifications, change notices, manufacturing procedures, equipment registrations and other documentation).
- Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.Build Quality into all aspects of work.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations.
- Attend all required Quality & Compliance training at the specified interval.
- Report any non-compliance issues to Chief QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.
- Meet 21 CFR 820, 801, 803, 806 and any other applicable federal regulations, and Quality standards.
- Responsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the effects on the environment.
- Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
- Responsible for understanding and conforming with the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.
Required Qualifications :
- BS Biomedical, Mechanical or Manufacturing Engineering.
- Minimum 3 years of related experience in manufacturing / quality / compliance.
- General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
- Experience with process and equipment validations/qualifications.
- Strong technical and analytical ability; detail oriented.
- Computer skills including, but not limited to: Microsoft Windows, Word, Excel.
- Basic understanding of statistical analysis.
Contact: Bill Zukowsky