Quality Systems Specialist
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Job Location:
Hampton, VA - USA
Monthly Salary:
Not Disclosed
Posted on:
1 hour ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Quality Systems Specialist
Work Location: Hampton VA
Domain: Manufacturing/Industrial/Production/Machinery
Work Hours: 2nd shift 3pm-11:30pm
Visa: Only US Citizen
Position Summary
The Quality Systems Specialist is responsible for supporting maintaining and continually improving the companys Quality Management System (QMS) and its associated subsystems. This role focuses on the development control and maintenance of Objective Quality Evidence (OQE) to demonstrate compliance with applicable standards customer requirements and regulatory obligations.
The position plays a key role in internal and external audits corrective action activities and integration of quality system requirements into operational and safety-related processes. Success in this role requires strong organizational skills technical aptitude persistence and the ability to see tasks through to completion.
Organizational Independence
This role is granted organizational independence to report quality system performance audit results and compliance concerns without undue influence and to elevate issues impacting product quality system effectiveness or safety.
Essential Duties and Responsibilities
Quality Management System (QMS) Support
Support the maintenance and improvement of the Quality Management System in accordance with ISO 9001 / AS9100 and applicable customer and regulatory requirements
Administer and support QMS subsystems including but not limited to:
Document and record control
Corrective and preventive action (CAPA)
Risk management activities
Training and competency records
Supplier quality system interfaces
Ensure quality procedures work instructions and records are current controlled and properly implemented
Objective Quality Evidence (OQE) Development
Develop assemble review and maintain Objective Quality Evidence (OQE) packets to demonstrate process and product compliance
Read and interpret engineering drawings specifications procedures and customer requirements to determine required evidence
Proactively chase down missing or incomplete documentation across departments to ensure OQE packages are complete accurate and audit-ready
Ensure quality evidence is objective traceable and generated at the point of work
Audit Support
Plan conduct and document internal quality audits in accordance with the established audit program
Support external audits including certification audits customer audits and regulatory audits
Track audit findings corrective actions and verification of effectiveness
Identify systemic issues and opportunities for improvement based on audit results and trend analysis
Corrective Action and Continuous Improvement
Support the corrective action process including:
Development of clear problem statements
Evidence-based root cause analysis
Verification of corrective action effectiveness
Monitor and report on quality system performance metrics
Support continual improvement initiatives aligned with company quality objectives
Safety Program Support
Support integration of quality system requirements into the company safety program
Assist with documentation control corrective action tracking and audit activities related to safety
Support investigations and follow-up activities related to safety incidents as required
Customer and Cross-Functional Interface
Interface professionally with internal departments customers and external auditors as needed
Support responses to customer quality inquiries and documentation requests
Promote a culture of compliance accountability and continuous improvement
Required Qualifications
Associates degree technical training or equivalent experience in quality manufacturing or a related field
3-6 years of experience in quality assurance quality systems or a regulated manufacturing environment
Working knowledge of Quality Management Systems (ISO 9001 AS9100 or equivalent)
Demonstrated experience developing and maintaining Objective Quality Evidence (OQE)
Ability to read and interpret engineering drawings specifications procedures and controlled documents
Strong organizational skills with the ability to manage multiple tasks from assignment through completion
Proven persistence and follow-through in resolving incomplete or missing documentation
Ability to work independently with minimal supervision
Preferred Qualifications
Experience conducting or supporting internal and external quality audits
Experience supporting or interfacing with a safety program (documentation audits corrective actions or investigations)
Experience in regulated industries (aerospace defense shipbuilding nuclear or similar)
Experience interfacing directly with customers or external auditors
Internal Auditor training or certification (ISO 9001 / AS9100)
Key Competencies and Behavioral Traits
High attention to detail and respect for controlled processes
Strong sense of ownership and accountability
Tenacity in chasing issues and documentation to closure
Ability to prioritize work and manage competing demands
Clear written and verbal communication skills
Objective evidence-based decision-making mindset
Physical and Work Environment Requirements
Standard office and manufacturing environment
Ability to sit stand and walk throughout the workday as required
Ability to review drawings documents and records for extended period.
Vishal (Victor) Verma Assistant Manager
NS IT Solutions
Work Location: Hampton VA
Domain: Manufacturing/Industrial/Production/Machinery
Work Hours: 2nd shift 3pm-11:30pm
Visa: Only US Citizen
Position Summary
The Quality Systems Specialist is responsible for supporting maintaining and continually improving the companys Quality Management System (QMS) and its associated subsystems. This role focuses on the development control and maintenance of Objective Quality Evidence (OQE) to demonstrate compliance with applicable standards customer requirements and regulatory obligations.
The position plays a key role in internal and external audits corrective action activities and integration of quality system requirements into operational and safety-related processes. Success in this role requires strong organizational skills technical aptitude persistence and the ability to see tasks through to completion.
Organizational Independence
This role is granted organizational independence to report quality system performance audit results and compliance concerns without undue influence and to elevate issues impacting product quality system effectiveness or safety.
Essential Duties and Responsibilities
Quality Management System (QMS) Support
Support the maintenance and improvement of the Quality Management System in accordance with ISO 9001 / AS9100 and applicable customer and regulatory requirements
Administer and support QMS subsystems including but not limited to:
Document and record control
Corrective and preventive action (CAPA)
Risk management activities
Training and competency records
Supplier quality system interfaces
Ensure quality procedures work instructions and records are current controlled and properly implemented
Objective Quality Evidence (OQE) Development
Develop assemble review and maintain Objective Quality Evidence (OQE) packets to demonstrate process and product compliance
Read and interpret engineering drawings specifications procedures and customer requirements to determine required evidence
Proactively chase down missing or incomplete documentation across departments to ensure OQE packages are complete accurate and audit-ready
Ensure quality evidence is objective traceable and generated at the point of work
Audit Support
Plan conduct and document internal quality audits in accordance with the established audit program
Support external audits including certification audits customer audits and regulatory audits
Track audit findings corrective actions and verification of effectiveness
Identify systemic issues and opportunities for improvement based on audit results and trend analysis
Corrective Action and Continuous Improvement
Support the corrective action process including:
Development of clear problem statements
Evidence-based root cause analysis
Verification of corrective action effectiveness
Monitor and report on quality system performance metrics
Support continual improvement initiatives aligned with company quality objectives
Safety Program Support
Support integration of quality system requirements into the company safety program
Assist with documentation control corrective action tracking and audit activities related to safety
Support investigations and follow-up activities related to safety incidents as required
Customer and Cross-Functional Interface
Interface professionally with internal departments customers and external auditors as needed
Support responses to customer quality inquiries and documentation requests
Promote a culture of compliance accountability and continuous improvement
Required Qualifications
Associates degree technical training or equivalent experience in quality manufacturing or a related field
3-6 years of experience in quality assurance quality systems or a regulated manufacturing environment
Working knowledge of Quality Management Systems (ISO 9001 AS9100 or equivalent)
Demonstrated experience developing and maintaining Objective Quality Evidence (OQE)
Ability to read and interpret engineering drawings specifications procedures and controlled documents
Strong organizational skills with the ability to manage multiple tasks from assignment through completion
Proven persistence and follow-through in resolving incomplete or missing documentation
Ability to work independently with minimal supervision
Preferred Qualifications
Experience conducting or supporting internal and external quality audits
Experience supporting or interfacing with a safety program (documentation audits corrective actions or investigations)
Experience in regulated industries (aerospace defense shipbuilding nuclear or similar)
Experience interfacing directly with customers or external auditors
Internal Auditor training or certification (ISO 9001 / AS9100)
Key Competencies and Behavioral Traits
High attention to detail and respect for controlled processes
Strong sense of ownership and accountability
Tenacity in chasing issues and documentation to closure
Ability to prioritize work and manage competing demands
Clear written and verbal communication skills
Objective evidence-based decision-making mindset
Physical and Work Environment Requirements
Standard office and manufacturing environment
Ability to sit stand and walk throughout the workday as required
Ability to review drawings documents and records for extended period.
Vishal (Victor) Verma Assistant Manager
NS IT Solutions
Required Skills:
SIT
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
