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Company | Johnson & Johnson |
Address | New Providence, NJ, United States |
Employment type | FULL_TIME |
Salary | |
Category | Hospitals and Health Care |
Expires | 2023-07-04 |
Posted at | 10 months ago |
- Implement and verify effectiveness of corrective and preventive actions (CAPA).
- Support material review board (MRB) with investigation and disposition of nonconforming materials.
- Collect and perform analysis of data such as manufacturing, shipping, sterilization data in support of quality objectives.
- Process validations (IQ, OQ, PQ) including as required the preparation of protocols and reports.
- Provide Quality support for design control activities for new and existing products.
- Applies industry and process excellence standards on a moderately complex level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
- A minimum of a Bachelor’s degree in Engineering is required. Biomedical engineering is preferred.
- Must have 2 years of experience in Quality Engineering
- Both, FDA, and ISO regulations knowledge is required.
- Strong communication, collaboration, and problem-solving skills are required.
- A demonstrated ability in a GMP and/or ISO regulated industry is required.
- Strong root cause analysis skills are required.
- Auditing background is preferred.
- Six Sigma, Lean, or ASQ Certification and trainings are preferred.
- FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
- Operations supplier quality experience is preferred.
- Experience in the medical device and/or pharmaceutical industry is preferred.
- Quality Engineer II - $68,900 to $111,090
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