Quality Assurance (QA) Lead Coordinator Job at Airswift Sweden (Port Neches)

Quality Assurance (QA) Lead Coordinator

Airswift Sweden

Location:
United States , Port Neches

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

The Quality Assurance (QA) Lead Coordinator is responsible for establishing, implementing, and maintaining the Quality Management System (QMS) to ensure full compliance with regulatory, customer, and internal requirements. This role drives continuous improvement within the Quality and Food Safety System, oversees validation activities, leads product safety initiatives, and manages audits, compliance, supplier oversight, and QMS certification programs. The QA Lead Coordinator ensures that products and processes meet the company's standards while promoting a culture of safety, quality, and regulatory excellence.

Job Responsibility:

Define and monitor KPIs with a continuous improvement focus
Maintain and control the Document Management System
Ensure compliance with the Quality and Safety Management System
Sustain existing certifications and drive corrective actions based on risk and nonconformity analysis
Implement new certifications aligned with strategic objectives
Ensure compliance with all applicable standards
Implement GMP practices across QA
Lead quality initiatives and training programs
Manage budgets and invoice processes
Provide QA-related support to cross-functional teams
Lead local Quality and Product Safety Committees
Facilitate management reviews
Coordinate recall, non-conformance, and food safety teams
Manage special projects (process mapping, SOP development, 5S implementation)
Maintain QMS/FSMS to sustain certifications
Develop and implement annual internal and external audit programs
Serve as Pharma/EXCiPACT specialist and lead pharmaceutical certification initiatives
Develop validation master plans, cleaning validations, CCP validations, and validation protocols
Ensure ongoing compliance with all validation plans and assess revalidation needs
Execute validations per approved protocols
Investigate system NCRs and conduct root cause and failure analyses
Develop and manage internal and external audit schedules
Define audit scopes, objectives, and timelines
Assign and qualify internal/external auditors and consultants
Oversee audit execution and ensure full compliance
Review, approve, and issue audit findings and reports
Track corrective actions through closure
Provide trend analyses and insights to leadership
Implement best practices in audit processes
Conduct internal audits and prepare results reports
Manage tracking and follow-up for all non-conformities
Lead root cause analysis activities
Ensure audit findings are fully documented and closed
Monitor quality metrics and report status to senior management
Maintain and implement certifications based on risk assessments and nonconformance trends
Support legal compliance assessments across all sites
Monitor Foreign Supplier Verification Program (FSVP – FDA) requirements
Qualify and monitor suppliers and support supplier audits
Manage supplier audit and internal audit schedules
Oversee supplier selection and performance monitoring
Manage customer-required documentation
Define and monitor KPIs aligned with continuous improvement initiatives
Drive quality and safety system compliance
Lead quality improvement initiatives and training
Implement and train teams on risk analysis methods (FMEA, HACCP)
Benchmark and apply best practices in quality improvement
Administer the Document Management System
Conduct quality onboarding for new employees
Investigate and respond to customer complaints and non-conformances
Participate in new product introduction (NPI) processes, providing QA review and approval
Manage department budgets and invoices
Support QA-related needs at other locations as required
Perform additional duties assigned by leadership

Requirements:

Establish, implement, and maintain the Quality Management System (QMS)
Ensure compliance with regulatory, customer, and internal requirements
Drive continuous improvement within the Quality and Food Safety System
Oversee validation activities
Lead product safety initiatives
Manage audits, compliance, supplier oversight, and QMS certification programs
Define and monitor KPIs with a continuous improvement focus
Maintain and control the Document Management System
Ensure compliance with the Quality and Safety Management System
Sustain existing certifications and drive corrective actions based on risk and nonconformity analysis
Implement new certifications aligned with strategic objectives
Ensure compliance with all applicable standards (ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC22000, EFfCI, Kosher, Halal)
Implement GMP practices across QA
Lead quality initiatives and training programs
Manage budgets and invoice processes
Provide QA-related support to cross-functional teams
Lead local Quality and Product Safety Committees
Facilitate management reviews
Coordinate recall, non-conformance, and food safety teams
Manage special projects (process mapping, SOP development, 5S implementation)
Maintain QMS/FSMS to sustain certifications including FSSC 22000, ISO 9001:2015, EFfCI, Kosher, Halal, RSPO
Develop and implement annual internal and external audit programs
Serve as Pharma/EXCiPACT specialist and lead pharmaceutical certification initiatives
Develop validation master plans, cleaning validations, CCP validations, and validation protocols
Ensure ongoing compliance with all validation plans and assess revalidation needs
Execute validations per approved protocols
Investigate system NCRs and conduct root cause and failure analyses
Develop and manage internal and external audit schedules
Define audit scopes, objectives, and timelines
Assign and qualify internal/external auditors and consultants
Oversee audit execution and ensure full compliance
Review, approve, and issue audit findings and reports
Track corrective actions through closure
Provide trend analyses and insights to leadership
Implement best practices in audit processes
Conduct internal audits and prepare results reports
Manage tracking and follow-up for all non-conformities
Lead root cause analysis activities
Ensure audit findings are fully documented and closed
Monitor quality metrics and report status to senior management
Maintain and implement certifications based on risk assessments and nonconformance trends
Support legal compliance assessments across all sites
Monitor Foreign Supplier Verification Program (FSVP – FDA) requirements
Qualify and monitor suppliers and support supplier audits
Manage supplier audit and internal audit schedules
Oversee supplier selection and performance monitoring
Manage customer-required documentation (questionnaires, quality agreements, contracts, statements)
Define and monitor KPIs aligned with continuous improvement initiatives
Drive quality and safety system compliance
Lead quality improvement initiatives and training
Implement and train teams on risk analysis methods (FMEA, HACCP)
Benchmark and apply best practices in quality improvement
Administer the Document Management System
Conduct quality onboarding for new employees
Investigate and respond to customer complaints and non-conformances
Participate in new product introduction (NPI) processes, providing QA review and approval
Manage department budgets and invoices
Support QA-related needs at other locations as required
Perform additional duties assigned by leadership

Additional Information:

Job Posted:
March 22, 2026

Airswift Sweden - All Job Offers

Job Link Share:

Quality Assurance (QA) Lead Coordinator

Airswift Sweden

Location:
United States , Port Neches

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 22, 2026

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Quality Assurance (QA) Lead Coordinator

Airswift Sweden

Location:United States , Port Neches

Category:Quality Control

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:March 22, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

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