Advion Interchim Scientific
Quality Assurance Manager
Advion Interchim Scientific, Mill Pond Village Mobile Home Park, Michigan, United States
About Advion, Inc.
Advion, Inc. is a global leader in analytical instrumentation, providing innovative solutions that advance scientific discovery. Our collaborative culture, commitment to quality, and focus on continuous improvement make Advion an exciting place to grow your career. Position Overview
Advion, Inc. is seeking a
Quality Assurance Manager
to lead the development, implementation, and maintenance of the company's Quality Management System (QMS) in alignment with
ISO standards
and applicable
U.S. export control regulations , including
ITAR (International Traffic in Arms Regulations)
and
EAR (Export Administration Regulations) . Reporting directly to the CEO, this role serves as the organizational authority for quality compliance, audit readiness, corrective and preventive actions (CAPA), and quality performance reporting. The Quality Assurance Manager oversees Quality Control personnel and works cross-functionally to ensure product integrity, regulatory compliance, and continuous improvement across operations, engineering, and manufacturing. Primary Responsibilities
Quality Management System (ISO Alignment)
Establish, maintain, and continuously improve the Quality Management System in accordance with applicable ISO standards
Ensure QMS documentation, records, and procedures are controlled, current, and audit-ready
Lead document control, record retention, and change management processes
Ensure consistent application of quality procedures across departments
Regulatory Compliance (ITAR & EAR)
Support company compliance with U.S. export control regulations, including ITAR and EAR, as they relate to quality systems, documentation, records, and controlled technical data
Ensure quality and QC documentation supports export compliance requirements, including traceability and access controls
Partner with leadership and relevant stakeholders to support internal controls, audits, and regulatory inquiries related to export compliance
Quality Control & Operational Oversight
Develop and manage Quality Control processes, including: Control of nonconforming material and disposition processes
Calibration compliance for inspection, measurement, and test equipment
Management of approved deviations, waivers, and concessions
Corrective and Preventive Action (CAPA) systems, including root cause analysis and effectiveness verification
Ensure quality records are accurate, complete, and retained per regulatory and internal requirements
Audits & Assessments
Plan, host, and lead internal audits to assess compliance with ISO standards, internal procedures, and regulatory requirements
Serve as the primary point of contact for external audits, including customer, certification body, and regulatory audits
Prepare audit documentation, manage findings, and ensure timely closure of corrective actions
Metrics, Reporting & Continuous Improvement
Define, track, analyze, and report quality metrics and key performance indicators (KPIs) to executive leadership
Identify trends and systemic risks impacting quality or compliance
Lead and support continuous improvement initiatives focused on process effectiveness, compliance, and risk reduction
Customer Quality & Warranty Management
Oversee warranty approval processes to ensure consistency, compliance, and traceability
Lead investigations into customer complaints, including root cause analysis and corrective actions
Interface with customers as needed on quality-related issues
Leadership & Personnel Management
Directly manage Quality Control personnel
Ensure QC staff are trained, qualified, and compliant with quality and regulatory requirements
Establish performance objectives, conduct evaluations, and support professional development
Promote a culture of quality ownership, ethical conduct, and continuous improvement
Required Qualifications
Bachelor's degree in engineering, science, or a related technical discipline
Demonstrated experience managing quality systems in an ISO-aligned environment
Working knowledge of quality control methodologies, audits, CAPA, and documentation control
Familiarity with ITAR and/or EAR requirements as they relate to documentation, records, and compliance controls
Proficiency with Microsoft Office (Word, Excel, Outlook)
Strong technical writing, documentation, and verbal communication skills
Preferred Qualifications
Prior experience in a regulated manufacturing, scientific, or technology environment
Experience managing or supporting export-controlled programs or products
Prior people-management or supervisory experience
Membership in professional quality or regulatory organizations
Work Environment & Physical Demands
Light office environment
Occasional interaction with manufacturing, laboratory, or controlled work areas as required
Performance Measures
Maintenance of ISO alignment and regulatory compliance
Successful audit outcomes and timely closure of corrective actions
Achievement of defined quality metrics and improvement objectives
Why Advion?
Competitive compensation ( $85,000 - $100,000 )
High-visibility role with direct executive engagement
Opportunity to lead and mature quality systems in a regulated, technology-focused organization
Collaborative culture emphasizing compliance, ethics, and continuous improvement
#J-18808-Ljbffr
Advion, Inc. is a global leader in analytical instrumentation, providing innovative solutions that advance scientific discovery. Our collaborative culture, commitment to quality, and focus on continuous improvement make Advion an exciting place to grow your career. Position Overview
Advion, Inc. is seeking a
Quality Assurance Manager
to lead the development, implementation, and maintenance of the company's Quality Management System (QMS) in alignment with
ISO standards
and applicable
U.S. export control regulations , including
ITAR (International Traffic in Arms Regulations)
and
EAR (Export Administration Regulations) . Reporting directly to the CEO, this role serves as the organizational authority for quality compliance, audit readiness, corrective and preventive actions (CAPA), and quality performance reporting. The Quality Assurance Manager oversees Quality Control personnel and works cross-functionally to ensure product integrity, regulatory compliance, and continuous improvement across operations, engineering, and manufacturing. Primary Responsibilities
Quality Management System (ISO Alignment)
Establish, maintain, and continuously improve the Quality Management System in accordance with applicable ISO standards
Ensure QMS documentation, records, and procedures are controlled, current, and audit-ready
Lead document control, record retention, and change management processes
Ensure consistent application of quality procedures across departments
Regulatory Compliance (ITAR & EAR)
Support company compliance with U.S. export control regulations, including ITAR and EAR, as they relate to quality systems, documentation, records, and controlled technical data
Ensure quality and QC documentation supports export compliance requirements, including traceability and access controls
Partner with leadership and relevant stakeholders to support internal controls, audits, and regulatory inquiries related to export compliance
Quality Control & Operational Oversight
Develop and manage Quality Control processes, including: Control of nonconforming material and disposition processes
Calibration compliance for inspection, measurement, and test equipment
Management of approved deviations, waivers, and concessions
Corrective and Preventive Action (CAPA) systems, including root cause analysis and effectiveness verification
Ensure quality records are accurate, complete, and retained per regulatory and internal requirements
Audits & Assessments
Plan, host, and lead internal audits to assess compliance with ISO standards, internal procedures, and regulatory requirements
Serve as the primary point of contact for external audits, including customer, certification body, and regulatory audits
Prepare audit documentation, manage findings, and ensure timely closure of corrective actions
Metrics, Reporting & Continuous Improvement
Define, track, analyze, and report quality metrics and key performance indicators (KPIs) to executive leadership
Identify trends and systemic risks impacting quality or compliance
Lead and support continuous improvement initiatives focused on process effectiveness, compliance, and risk reduction
Customer Quality & Warranty Management
Oversee warranty approval processes to ensure consistency, compliance, and traceability
Lead investigations into customer complaints, including root cause analysis and corrective actions
Interface with customers as needed on quality-related issues
Leadership & Personnel Management
Directly manage Quality Control personnel
Ensure QC staff are trained, qualified, and compliant with quality and regulatory requirements
Establish performance objectives, conduct evaluations, and support professional development
Promote a culture of quality ownership, ethical conduct, and continuous improvement
Required Qualifications
Bachelor's degree in engineering, science, or a related technical discipline
Demonstrated experience managing quality systems in an ISO-aligned environment
Working knowledge of quality control methodologies, audits, CAPA, and documentation control
Familiarity with ITAR and/or EAR requirements as they relate to documentation, records, and compliance controls
Proficiency with Microsoft Office (Word, Excel, Outlook)
Strong technical writing, documentation, and verbal communication skills
Preferred Qualifications
Prior experience in a regulated manufacturing, scientific, or technology environment
Experience managing or supporting export-controlled programs or products
Prior people-management or supervisory experience
Membership in professional quality or regulatory organizations
Work Environment & Physical Demands
Light office environment
Occasional interaction with manufacturing, laboratory, or controlled work areas as required
Performance Measures
Maintenance of ISO alignment and regulatory compliance
Successful audit outcomes and timely closure of corrective actions
Achievement of defined quality metrics and improvement objectives
Why Advion?
Competitive compensation ( $85,000 - $100,000 )
High-visibility role with direct executive engagement
Opportunity to lead and mature quality systems in a regulated, technology-focused organization
Collaborative culture emphasizing compliance, ethics, and continuous improvement
#J-18808-Ljbffr