This role will focus on driving CAPAs, Non-Conformances, investigations, and Quality System improvements while helping reduce quality backlog and ensuring compliance with regulatory requirements. Key ...
Quick apply
This role will focus on driving CAPAs, Non-Conformances, investigations, and Quality System improvements while helping reduce quality backlog and ensuring compliance with regulatory requirements. Key ...
Quick apply
This role will focus on driving CAPAs, Non-Conformances, investigations, and Quality System improvements while helping reduce quality backlog and ensuring compliance with regulatory requirements. Key ...
This role ensures effective execution of key quality system processes including document control, records management, EtQ administration, change management, training, CAPA, and Management Review. The ...
This role ensures effective execution of key quality system processes including document control, records management, EtQ administration, change management, training, CAPA, and Management Review. The ...
Improve and maintain the global Quality System in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada ...
Improve and maintain the global Quality System in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada ...
Improve and maintain the global Quality System in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada ...
Improve and maintain the global Quality System in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada ...
Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry. * Previous experience leading teams or projects. * Requires ...
Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry. * Previous experience leading teams or projects. * Requires ...
Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry. * Previous experience leading teams or projects. * Requires ...
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Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry. * Previous experience leading teams or projects. * Requires ...
Coordinates all areas of system development, including preparation, execution and installation support to assure quality system changes. * Identifies system enhancements, document business needs and ...
Coordinates all areas of system development, including preparation, execution and installation support to assure quality system changes. * Identifies system enhancements, document business needs and ...
Principal Responsibilities Plan, execute and document internal quality system audits Track audit observations and follow up on resolution Compile and report audit metrics Train and mentor site ...
Principal Responsibilities Plan, execute and document internal quality system audits Track audit observations and follow up on resolution Compile and report audit metrics Train and mentor site ...
Morrisville, NC · On-site
Principal Responsibilities • Plan, execute and document internal quality system audits • Track audit observations and follow up on resolution • Compile and report audit metrics • Train and ...
Morrisville, NC · On-site
Principal Responsibilities • Plan, execute and document internal quality system audits • Track audit observations and follow up on resolution • Compile and report audit metrics • Train and ...
Uses lean six sigma methodologies to advance systemic quality improvements through the GSK production system. * Ensure comprehensive training compliance for all relevant personnel, maintaining up-to ...
Uses lean six sigma methodologies to advance systemic quality improvements through the GSK production system. * Ensure comprehensive training compliance for all relevant personnel, maintaining up-to ...
Uses lean six sigma methodologies to advance systemic quality improvements through the GSK production system. * Ensure comprehensive training compliance for all relevant personnel, maintaining up-to ...
Uses lean six sigma methodologies to advance systemic quality improvements through the GSK production system. * Ensure comprehensive training compliance for all relevant personnel, maintaining up-to ...
This role ensures that the Quality System supports all stages of drug development - from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization ...
This role ensures that the Quality System supports all stages of drug development - from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization ...
This role ensures that the Quality System supports all stages of drug development -- from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization ...
Quick apply
This role ensures that the Quality System supports all stages of drug development -- from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization ...
Raleigh, NC · On-site
$86K - $116K/yr
Provides direction and leadership for quality system improvements and for benchmarking of other sites to establish and implement best practices. * Provides validation guidance and support for ...
Raleigh, NC · On-site
$86K - $116K/yr
Provides direction and leadership for quality system improvements and for benchmarking of other sites to establish and implement best practices. * Provides validation guidance and support for ...
Raleigh, NC · On-site
$86K - $116K/yr
Provides direction and leadership for quality system improvements and for benchmarking of other sites to establish and implement best practices. * Provides validation guidance and support for ...
Raleigh, NC · On-site
$86K - $116K/yr
Provides direction and leadership for quality system improvements and for benchmarking of other sites to establish and implement best practices. * Provides validation guidance and support for ...
Raleigh, NC · On-site
$23/hr
... Quality system requirements and the Eaton Quality System. In this function you will: • Assist in quality audits, workmanship defect reduction efforts, corrective and preventive action ...
Raleigh, NC · On-site
$23/hr
... Quality system requirements and the Eaton Quality System. In this function you will: • Assist in quality audits, workmanship defect reduction efforts, corrective and preventive action ...
Durham, NC · On-site
Experience with manufacturing ERP systems (SAP or IFS preferred). * Demonstrated competency with basic quality control processes, and a passion for right-the-first-time quality. * Ability to read and ...
Durham, NC · On-site
Experience with manufacturing ERP systems (SAP or IFS preferred). * Demonstrated competency with basic quality control processes, and a passion for right-the-first-time quality. * Ability to read and ...
Durham, NC · On-site
$130K - $160K/yr
Utilizes quality statistics to develop effective strategies to maintain and improve the performance of products and the quality system. Develops relationships with key development and manufacturing ...
Durham, NC · On-site
$130K - $160K/yr
Utilizes quality statistics to develop effective strategies to maintain and improve the performance of products and the quality system. Develops relationships with key development and manufacturing ...
Raleigh, NC · On-site
$130K - $160K/yr
Utilizes quality statistics to develop effective strategies to maintain and improve the performance of products and the quality system. Develops relationships with key development and manufacturing ...
Raleigh, NC · On-site
$130K - $160K/yr
Utilizes quality statistics to develop effective strategies to maintain and improve the performance of products and the quality system. Develops relationships with key development and manufacturing ...
Durham, NC · On-site
Experience with manufacturing ERP systems (SAP or IFS preferred). * Demonstrated competency with basic quality control processes, and a passion for right-the-first-time quality. * Ability to read and ...
Durham, NC · On-site
Experience with manufacturing ERP systems (SAP or IFS preferred). * Demonstrated competency with basic quality control processes, and a passion for right-the-first-time quality. * Ability to read and ...
$13.55 - $15.32
7% of jobs
$15.32 - $17.08
2% of jobs
$17.08 - $18.84
3% of jobs
$18.84 - $20.61
10% of jobs
$22.07 is the 25th percentile. Wages below this are outliers.
$20.61 - $22.37
3% of jobs
$22.37 - $24.13
14% of jobs
$24.13 - $25.89
10% of jobs
The median wage is $25.98 / hr.
$25.89 - $27.66
22% of jobs
$27.97 is the 75th percentile. Wages above this are outliers.
$27.66 - $29.42
21% of jobs
$29.42 - $31.18
4% of jobs
$31.18 - $32.95
3% of jobs
$13
$24
$32
| Aspect | Quality System | Quality Assurance |
|---|---|---|
| Definition | Framework of policies, processes, and procedures to ensure quality management across an organization. | Part of the quality system focused on preventing defects through planned activities and systematic processes. |
| Focus | Overall quality management and compliance | Preventing defects and ensuring product/service quality |
| Certifications | ISO 9001, QS-9000 | ISO 9001, Six Sigma, CQA |
| Work Environment | Cross-departmental, organizational-wide | Specific to quality processes and audits |
In summary, a Quality System encompasses the entire framework for managing quality within an organization, including policies and procedures. Quality Assurance is a key component of the Quality System, focusing specifically on preventing defects and ensuring quality through systematic activities.

Contractor
Posted 20 days ago
Hi,
My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Quality Engineer/Quality Systems Specialist position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows
Position: Contract Quality Engineer / Quality Systems Specialist
Location: Durham, NC
Duration: Long Term
Job Overview
We are seeking an experienced Quality Engineer / Quality Systems Specialist to support a fast-paced FDA-regulated medical device manufacturing environment. This role will focus on driving CAPAs, Non-Conformances, investigations, and Quality System improvements while helping reduce quality backlog and ensuring compliance with regulatory requirements.
Key Responsibilities
Required Qualifications
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/
Thank you,
Karthik Mutyala
Recruiting Manager
Stark Pharma Solutions Inc
Email: karthik@starkpharma.com
15 Corporate Place S, Suite 350,
Piscataway, New Jersey 08854
www.starkpharma.com