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Sr. Quality Engineer - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | MONTGOMERY, AL MONTGOMERY, Alabama |
About this job
Summary
Provide the manufacturing floor with Quality Engineering support for current products and perform as liaison between Quality Assurance and Regulatory Affairs and Manufacturing.
Responsibilities
Resolve short and long term quality issues with suppliers, both internal and external.
Lead quality system internal and external audits. Prepare reports including summary conclusions/acceptance of internal/external assemblies, products, or systems.
Investigate production line stopping failures and identify corrective actions to be taken to return to normal operation.
Ensure quality system compliance to ISO and FDA compliance standards
Support Customer quality complaints and assist in resolution in accordance with customer needs and compliance standards.
Provide integral new product development support relative to design, development, testing, and introduction, production, and ongoing process improvements.
Author and review Engineering Change Requests and Vendor Variation Requests to meet product and production goals.
Contribute to evaluation of field failures, including problem analysis and resolution for both the customer and ongoing improvement efforts.
Provide technical expertise for Quality Systems techniques, and training for facility departments and individuals. Prepare and present presentations on areas of expertise.
Lead weekly product improvement team meetings. Resolve disputes and reach consensus on actions to be taken.
Assist in third party audits of the facility including, FDA, ISO, or customer representatives. Also serve as backup Management Representative in certain situations.
Qualifications
Bachelor s degree (Industrial, Mechanical, or Electrical Engineering); Masters degree preferred.
2. Requires knowledge of Quality methods and investigational techniques to determine root cause of problems; ability to read and interpret technical drawings.
3. 3-5 years experience in manufacturing Quality role desired; including 3-5 years experience with FDA QSRs and ISO 9000 series standards and auditing products or systems to these requirements
4. Familiarity with Personal Computers and related software (WordPerfect, Microsoft Office).
5. Effective communication with peers, management, external customers and professional and government organizations, both verbal and written
6. ASQ CQA or CQE Certification desired; other Quality Regulatory Certifications preferred (RAC, CRE, CQMgr etc)
Lean manufacturing knowledge and experience desired
8. Basic 5S knowledge and experience
9. Proficient in waste identification and elimination methods
Provide the manufacturing floor with Quality Engineering support for current products and perform as liaison between Quality Assurance and Regulatory Affairs and Manufacturing.
Responsibilities
Resolve short and long term quality issues with suppliers, both internal and external.
Lead quality system internal and external audits. Prepare reports including summary conclusions/acceptance of internal/external assemblies, products, or systems.
Investigate production line stopping failures and identify corrective actions to be taken to return to normal operation.
Ensure quality system compliance to ISO and FDA compliance standards
Support Customer quality complaints and assist in resolution in accordance with customer needs and compliance standards.
Provide integral new product development support relative to design, development, testing, and introduction, production, and ongoing process improvements.
Author and review Engineering Change Requests and Vendor Variation Requests to meet product and production goals.
Contribute to evaluation of field failures, including problem analysis and resolution for both the customer and ongoing improvement efforts.
Provide technical expertise for Quality Systems techniques, and training for facility departments and individuals. Prepare and present presentations on areas of expertise.
Lead weekly product improvement team meetings. Resolve disputes and reach consensus on actions to be taken.
Assist in third party audits of the facility including, FDA, ISO, or customer representatives. Also serve as backup Management Representative in certain situations.
Qualifications
Bachelor s degree (Industrial, Mechanical, or Electrical Engineering); Masters degree preferred.
2. Requires knowledge of Quality methods and investigational techniques to determine root cause of problems; ability to read and interpret technical drawings.
3. 3-5 years experience in manufacturing Quality role desired; including 3-5 years experience with FDA QSRs and ISO 9000 series standards and auditing products or systems to these requirements
4. Familiarity with Personal Computers and related software (WordPerfect, Microsoft Office).
5. Effective communication with peers, management, external customers and professional and government organizations, both verbal and written
6. ASQ CQA or CQE Certification desired; other Quality Regulatory Certifications preferred (RAC, CRE, CQMgr etc)
Lean manufacturing knowledge and experience desired
8. Basic 5S knowledge and experience
9. Proficient in waste identification and elimination methods
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