Job Summary
- Company
- The Denzel Group
- Location
- Eatontown, NJ 07724
- Industries
- Biotechnology/Pharmaceuticals
- Medical Devices and Supplies
- Job Type
- Full Time
- Employee
Quality Engineer
About the Job
QA Engineer
The Denzel Group has been selected to work with a great growing company in Eastern New Jersey that is looking for a QA Engineer that plans, develops, maintains, and manages portions of the Quality Control program for our client. At this company you will have direct involvement with Regulatory Affairs, Product Development, Validation, Operations, Sales and Marketing, and Purchasing in matters concerning Quality control inspection, supplier qualification, validation, product stability, and documentation. You will also ensure that products released to the market meet the desired quality specifications and attributes through engineering analysis and testing. You may have managerial responsibilities of a small team.
EXPERIENCE
**Minimum of eight (8) years of professional managerial experience in a quality engineering role preferable in a medical device, pharmaceuticals, biologics or aseptic processing company.
**Fluent in cGMPs, AATB, GTPs, ISO and FDA regulations and compliance.
**Knowledge of industry test standards e.g. ASTM, ISO, USP, etc.
**Experience with multiple types of manufacturing product lines, water systems, sterilization.
RESPOSIBILITIES Include...
**Participating in the development, planning, implementation, and maintenance of related methods and technology applications that meet the required standards of aseptic and terminally sterilized bio-pharmaceutical production.
**Supporting the design and development of new products and participate in process design and development activities. Responsible for preparing the quality plan and determining the test methodologies to be used for routine quality control of products. Coordinates testing with Quality Control laboratories for product safety and or other required tests.
**Interacting with the Product Development and Operations to assure statistically based quality systems intended for use in the quantitative measurement of process variability.
**Participating in risk analysis for product designs and processes. Responsible for improvements to products through the results of failure analysis and recommend design changes based on testing or regulatory agency requirements.
**Ensuring verification testing of medical devices using proven methods under design control guidelines.
**Responsible for standardizing and optimizing product testing and inspection procedures and supervise the QC inspection group, as applicable.
**Responsible for maintaining the mom-conformance system ad design systems for tracking and trending of non-conformances. Apply problem solving techniques (e.g. root cause analysis) to resolve non-conformance and customer complaints. Assess and report on level of compliance and other areas of potential risk to Company business.
EDUCATION:
Bachelor of Science degree in scientific discipline or engineering degree, ASQ certification: CQE
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Contact Information
The Denzel Group
