QA Project Coordinator

DWYER INSTRUMENTS, LLC•Simi Valley, CA

About The Position

This position requires overseeing and maintaining the company’s Quality Management System and helping Engineering with all projects. Our (QMS) is to ensure compliance with applicable quality standards, regulatory requirements, managing and customer expectations. This role supports company-wide quality initiatives across calibration services, software/cloud operations, customer support processes, supplier management, and product development activities. This role is responsible for audits, compliance programs, CAPA investigations, document control, risk management, and continuous improvement initiatives while collaborating cross-functionally with engineering, production, support, operations, accounting, and executive leadership. This role also supports strategic initiatives related to regulated industries, including pharmaceutical and laboratory environments, ensuring systems and processes align with ISO 9001, ISO/IEC 17025, and customer compliance expectations.

Requirements

Minimum 3+ years of experience in Quality Assurance, Quality Systems, and project management
Strong knowledge of ISO 9001 and/or ISO/IEC 17025 standards.
Experience managing CAPAs, audits, document control, and root cause investigations.
Familiarity with regulated industries such as pharmaceutical, laboratory, manufacturing, or medical environments preferred.
Strong organizational, communication, and problem-solving skills.
Ability to manage multiple projects and priorities independently.
Experience working cross-functionally with engineering, production, and operations teams.
Experience with eQMS systems and electronic documentation systems preferred.
Leadership and accountability
Attention to detail
Regulatory and compliance mindset
Critical thinking and root cause analysis
Project management
Cross-functional collaboration
Process improvement and continuous improvement
Strong documentation and communication skill

Nice To Haves

Experience supporting cloud/software quality processes.
Knowledge of data integrity and audit trail requirements.
Experience with supplier quality management and risk assessments.
Familiarity with validation documentation (IQ/OQ/PQ).
Strong written communication skills for customer facing compliance responses and audit documentation.
eQMS systems and electronic documentation systems

Responsibilities

Manage and maintain the company Quality Management System (QMS) in compliance with ISO 9001 and ISO/IEC 17025 requirements.
Develop, revise, implement, and control SOPs, work instructions, forms, policies, and quality records.
Oversee document control, revision management, training records, and quality documentation retention.
Lead internal audits, management reviews, and continuous improvement initiatives.
Ensure periodic review and effectiveness of quality procedures and controlled documents.
Support migration and implementation of electronic Quality Management Systems (eQMS) to DOT Compliance.
Ensure compliance with customer, regulatory, and accreditation requirements.
Support audit readiness activities for customer audits, supplier audits, accreditation audits, and regulatory inspections.
Manage CAPAs, nonconformances, deviations, root cause investigations, and corrective actions.
Conduct risk assessments for suppliers, processes, and quality systems.
Support quality and compliance requirements related to environmental monitoring systems and pharmaceutical customers.
Assist with validation-related documentation including IQ/OQ/PQ support activities.
Collaborate with engineering, software, production, calibration, and support teams to improve processes and product quality.
Review quality impacts associated with software/cloud platform changes, audit trail functionality, data integrity, and traceability requirements.
Support implementation of data integrity controls and audit trail visibility requirements.
Participate in product development discussions to ensure quality and compliance considerations are incorporated into new products and platform improvements.
Support customer complaint investigations and resolution activities.
Assist leadership with quality planning, operational improvements, and compliance strategies.
Qualify, evaluate, and monitor suppliers and critical vendors.
Conduct supplier risk assessments and performance reviews.
Support supplier corrective actions and vendor quality improvement initiatives.
Maintain approved supplier documentation and quality agreements.
Respond to customer quality questionnaires, security assessments, and compliance requests.
Prepare audit-ready documentation and evidence for customers and auditors.
Support customer communications related to quality events, CAPAs, data integrity, and compliance matters.
Coordinate audit schedules, audit responses, and follow-up actions.
Develop and coordinate employee training programs related to quality systems and compliance.
Promote quality awareness and continuous improvement throughout the organization.
Train personnel on SOPs, work instructions, and quality procedures.
Support cloud and software compliance initiatives related to data retention, audit trails, cybersecurity, and traceability.
Assist with process standardization and operational scalability initiatives.
Monitor and report quality metrics, trends, and KPIs to leadership.
Support implementation of process improvements and preventive quality measures.
Coordinate with global teams and external partners as needed.