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Quality Assurance Manager - ISO 13485 - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | HAUPPAUGE, NY HAUPPAUGE, New York |
About this job
Quality Assurance Manager for a well-established medical device company located near Hauppauge, NY needed!
The successful candidate will have a solid understanding of ISO 13485 and FDA regulations. This is a MUST!
Summary:
Overall management of the Quality Inspection and Assurance functions. Review Quality Assurance Procedures (QAPs) and develop new procedures as necessary. Resolve complex quality issues, evaluate product and processes to ensure product quality is not compromised. Work under minimal supervision. Manage 4-5 employees.
Essential Functions:
- Oversee Quality Inspection from Incoming to Final.
- Maintain / enhance the ISO 13485 Quality System, develop procedures and forms, perform failure analysis, product dispositions, resolve quality issues and develop corrective actions.
- Provides support for existing products; disposition of non-conforming material, work with suppliers, evaluate customer complaints.
- Other functions as needed
Requirements:
- Bachelor’s Degree in related field
- Minimum 3-5 years of experience with regulatory management in the medical device industry
- Solid understanding of ISO 13485 and FDA regulations
- Certified Quality Auditor (CQA)
- Good working knowledge of Risk Analysis (ISO 14971)
- Proficient with MS Office Suite
- Excellent communication skills, both oral and written
Salary is competitive and commensurate with experience + benefits
The successful candidate will have a solid understanding of ISO 13485 and FDA regulations. This is a MUST!
Summary:
Overall management of the Quality Inspection and Assurance functions. Review Quality Assurance Procedures (QAPs) and develop new procedures as necessary. Resolve complex quality issues, evaluate product and processes to ensure product quality is not compromised. Work under minimal supervision. Manage 4-5 employees.
Essential Functions:
- Oversee Quality Inspection from Incoming to Final.
- Maintain / enhance the ISO 13485 Quality System, develop procedures and forms, perform failure analysis, product dispositions, resolve quality issues and develop corrective actions.
- Provides support for existing products; disposition of non-conforming material, work with suppliers, evaluate customer complaints.
- Other functions as needed
Requirements:
- Bachelor’s Degree in related field
- Minimum 3-5 years of experience with regulatory management in the medical device industry
- Solid understanding of ISO 13485 and FDA regulations
- Certified Quality Auditor (CQA)
- Good working knowledge of Risk Analysis (ISO 14971)
- Proficient with MS Office Suite
- Excellent communication skills, both oral and written
Salary is competitive and commensurate with experience + benefits