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.
Essential Responsibilities
Quality Management System (QMS)
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Manage and maintain the company Quality Management System (QMS) in compliance with ISO 9001 and ISO/IEC 17025 requirements.
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Develop, revise, implement, and control SOPs, work instructions, forms, policies, and quality records.
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Oversee document control, revision management, training records, and quality documentation retention.
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Lead internal audits, management reviews, and continuous improvement initiatives.
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Ensure periodic review and effectiveness of quality procedures and controlled documents.
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Support migration and implementation of electronic Quality Management Systems (eQMS) to DOT Compliance.
Compliance & Regulatory Oversight
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Ensure compliance with customer, regulatory, and accreditation requirements.
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Support audit readiness activities for customer audits, supplier audits, accreditation audits, and regulatory inspections.
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Manage CAPAs, nonconformances, deviations, root cause investigations, and corrective actions.
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Conduct risk assessments for suppliers, processes, and quality systems.
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Support quality and compliance requirements related to environmental monitoring systems and pharmaceutical customers.
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Assist with validation-related documentation including IQ/OQ/PQ support activities.
Cross-Functional Quality Support
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Collaborate with engineering, software, production, calibration, and support teams to improve processes and product quality.
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Review quality impacts associated with software/cloud platform changes, audit trail functionality, data integrity, and traceability requirements.
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Support implementation of data integrity controls and audit trail visibility requirements.
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Participate in product development discussions to ensure quality and compliance considerations are incorporated into new products and platform improvements.
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Support customer complaint investigations and resolution activities.
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Assist leadership with quality planning, operational improvements, and compliance strategies.
Supplier & Vendor Quality Management
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Qualify, evaluate, and monitor suppliers and critical vendors.
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Conduct supplier risk assessments and performance reviews.
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Support supplier corrective actions and vendor quality improvement initiatives.
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Maintain approved supplier documentation and quality agreements.
Customer & Audit Support
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Respond to customer quality questionnaires, security assessments, and compliance requests.
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Prepare audit-ready documentation and evidence for customers and auditors.
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Support customer communications related to quality events, CAPAs, data integrity, and compliance matters.
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Coordinate audit schedules, audit responses, and follow-up actions.
Training & Quality Culture
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Develop and coordinate employee training programs related to quality systems and compliance.
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Promote quality awareness and continuous improvement throughout the organization.
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Train personnel on SOPs, work instructions, and quality procedures.
Additional Responsibilities
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Support cloud and software compliance initiatives related to data retention, audit trails, cybersecurity, and traceability.
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Assist with process standardization and operational scalability initiatives.
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Monitor and report quality metrics, trends, and KPIs to leadership.
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Support implementation of process improvements and preventive quality measures.
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Coordinate with global teams and external partners as needed.
Required Qualifications
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Minimum 3+ years of experience in Quality Assurance, Quality Systems, and project management
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Strong knowledge of ISO 9001 and/or ISO/IEC 17025 standards.
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Experience managing CAPAs, audits, document control, and root cause investigations.
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Familiarity with regulated industries such as pharmaceutical, laboratory, manufacturing, or medical environments preferred.
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Strong organizational, communication, and problem-solving skills.
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Ability to manage multiple projects and priorities independently.
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Experience working cross-functionally with engineering, production, and operations teams.
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Experience with eQMS systems and electronic documentation systems preferred.
Preferred Skills
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Experience supporting cloud/software quality processes.
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Knowledge of data integrity and audit trail requirements.
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Experience with supplier quality management and risk assessments.
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Familiarity with validation documentation (IQ/OQ/PQ).
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Strong written communication skills for customer facing compliance responses and audit documentation.
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eQMS systems and electronic documentation systems
Key Competencies
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Leadership and accountability
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Attention to detail
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Regulatory and compliance mindset
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Critical thinking and root cause analysis
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Project management
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Cross-functional collaboration
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Process improvement and continuous improvement
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Strong documentation and communication skill
We believe in transparent and equitable pay. All U.S. job postings include a good-faith salary range based on role, locations, experience, and internal equity. We're happy to discuss compensation openly throughout the hiring process.;pp
