Advion Interchim Scientific · 1 week ago
Quality Assurance Manager
Advion, Inc. is a global leader in analytical instrumentation, providing innovative solutions that advance scientific discovery. The Quality Assurance Manager will lead the development and implementation of the company's Quality Management System in alignment with ISO standards and ensure compliance with U.S. export control regulations.
Chemical EngineeringElectronicsIndustrial Engineering
Responsibilities
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
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
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
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
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
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
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
Qualification
Required
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
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
Benefits
Health, dental, and vision insurance
401(k) with company match
Paid time off
Life and disability coverage
Flexible spending accounts
Additional perks aimed at supporting work-life balance and professional growth
Company
Advion Interchim Scientific
Advion Interchim Scientific specializes in chromatography, purification, and the design and development of novel mass spectrometry systems.
H1B Sponsorship
Advion Interchim Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
Company data provided by crunchbase