What are the responsibilities and job description for the Quality Engineer position at Jobot?
Job Description
A High Quality Plastics manufacturing company that has been in business for over 75 years! Great pay, Great Benefits, opportunity for growth!
This Jobot Job is hosted by: Jerry Garcia
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000 - $100,000 per year
A bit about us:
A Family owed worldwide plastics manufacturing company that has been in business for over 75 years and specializes in the Healthcare Industry. Our Engineering team is growing and looking to add a Quality Engineer.
Why join us?
401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Job Details
1. Use of statistical tools to facilitate design verification test sample size and test method validations.
2. Lead Risk Analysis (FMEA-CA Design/ Process) meetings and generate final reports and actions requirements.
3. Perform analyses of failed material in order to determine the root cause. Implement appropriate corrective actions.
4. Work on new product transfers and actively participate in the qualifications and validations of product/ equipment and processes.
5. Review and approve document changes (process and design).
6. Assist R&D in test method development and conduct test method validation.
7. Participate on internal quality audits.
8. Develop and implement quality systems in compliance with ISO certification.
9. Review and approve receiving inspection requirements and sampling plans for components. Develop and improve QC inspection and testing method as needed.
10. Backfill quality review, QC testing, receiving inspection and product release activities as required.
11. Support the implementation of overall company validation strategy
12. Perform role to ensure all validations are in compliance with company policies and procedures
13. Assess, process and circulate protocols and final reports for review and approval
14. Execute each phase of the validation and/or solicit support to ensure adherence to the protocol requirements.
15. Report and document Protocol exceptions
16. Liaise with scheduling/planning and sales as required to ensure communication and documentation flow throughout the process.
17. Provide feedback to appropriate personnel on the validation activities and project status.
Must Haves:
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
This Jobot Job is hosted by: Jerry Garcia
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000 - $100,000 per year
A bit about us:
A Family owed worldwide plastics manufacturing company that has been in business for over 75 years and specializes in the Healthcare Industry. Our Engineering team is growing and looking to add a Quality Engineer.
Why join us?
401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Job Details
1. Use of statistical tools to facilitate design verification test sample size and test method validations.
2. Lead Risk Analysis (FMEA-CA Design/ Process) meetings and generate final reports and actions requirements.
3. Perform analyses of failed material in order to determine the root cause. Implement appropriate corrective actions.
4. Work on new product transfers and actively participate in the qualifications and validations of product/ equipment and processes.
5. Review and approve document changes (process and design).
6. Assist R&D in test method development and conduct test method validation.
7. Participate on internal quality audits.
8. Develop and implement quality systems in compliance with ISO certification.
9. Review and approve receiving inspection requirements and sampling plans for components. Develop and improve QC inspection and testing method as needed.
10. Backfill quality review, QC testing, receiving inspection and product release activities as required.
11. Support the implementation of overall company validation strategy
12. Perform role to ensure all validations are in compliance with company policies and procedures
13. Assess, process and circulate protocols and final reports for review and approval
14. Execute each phase of the validation and/or solicit support to ensure adherence to the protocol requirements.
15. Report and document Protocol exceptions
16. Liaise with scheduling/planning and sales as required to ensure communication and documentation flow throughout the process.
17. Provide feedback to appropriate personnel on the validation activities and project status.
Must Haves:
- Willingness to learn and adapt to varying priorities
- Bachelor of Science or related discipline
- Experience and Knowledge in Good Manufacturing Practices (GMPs) and Quality Systems and ISO-13485.
- Propose innovative practices to ensure processes are efficiently validated and product could be available for sale to the appropriate market.
- Experience with medical instrumentation and disposables, in a regulatory environment (i.e. GMPs, ISO9001, ISO13485, etc.).
- Proficient in knowledge of variety of testing equipment (including Introns, pin gages, snap gages, micrometer, caliper, etc.).
- Proficient technical writing skills and use of documentation programs (e.g. Office Windows, Excel, Access, Power Point, etc.).
- Working knowledge of fundamental quality and statistical tools including SPC, DOE, Six Sigma And ISO-13485.
- ASQ Certified Quality Engineer Preferred.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Salary : $80,000 - $100,000
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