Quality Management Systems Specialist

Position Summary

Our Analytical Solutions product line business has an exciting opportunity available for a Quality Management System (QMS) Specialist. The QMS Specialist will be responsible for managing all aspects of site-wide ISO compliance efforts including facilitating external and internal audits of the quality management system and product regulatory compliance. A key interface with operations, engineering, manufacturing, supply chain, logistics, customers, vendors, and third‑party compliance partners to ensure quality management systems requirements are met.

The person in this role must develop training materials to continually improve an ISO certified site, evaluate risk by auditing product quality plans, design and development records, and other QMS related documented information. Coordinates site-wide customer and third‑party compliance audits, makes recommendations for corrective actions and risk‑reducing measures based on audit findings.

• Lead the development, implementation, and improvement of the Company’s QMS to maintain compliance to ISO requirements (ISO 9001, ISO 17025, and ISO 17034)
• Author, review, or revise QMS relevant controlled documents
• Support QMS alignment with other company programs and management system
• Coordinate QMS internal and external audits
• Administrator for QMS related business systems such as QMS document control, QMS record controls, and QMS learning management
• Develop and facilitate QMS training plans
• Manage the QMS Corrective Actions process and confirm effectiveness
• Develop, implement, maintain, and improve quality assurance systems, including tools, policies, training and processes
• Assist problem‑solving team and participate in continuous improvement initiatives
• Manage quality data for accuracy and report generation
• Ensure processes for products and services conform to established company, customer, and regulatory requirements
• Support product compliance regulations (RoHS, REACH, Conflict Minerals, etc.) and document compliance for customer inquiries
• Review, analyze and report on quality discrepancies related to processes
• Improve training and auditing, following up with process owners for lean, focused improvements while leveraging the Plan‑Do‑Check‑Act (PDCA) cycle
• Comply with all company policies including inclusion and diversity, quality, and environmental, health, and safety

The ideal candidate will have excellent quality compliance skills and experience to be part of a high performing quality team to ensure regulatory compliance in an exciting, fast‑paced business. This role will help develop and lead compliance to international quality standards, lead change throughout the business, partner cross‑functionally to innovate new ideas, and implement best‑in‑class quality programs.

• Quality Assurance and/or Lean Six Sigma Certification
• Certified lead auditor ISO 9001:2015 and working experience as an ISO internal auditor
• Project planning and organization
• Experience developing QMS documents, procedures, and working instructions
• Experience in problem‑solving methodologies such as PDCA, root cause corrective action (RCA and CAPA)
• Knowledge and application of quality concepts such as Lean Manufacturing, 5s, Six Sigma, ISO 9001:2015, ISO 17025:2017, ISO 17034:2016 standards
• Cross‑organizational collaboration and influencing decisions
• Cross‑organizational business prioritization
• Proficient in Google Suite applications and common AI tools; business software such as SAP, Salesforce, and Tableau
• Effective and engaging presentation skills
• Written and oral communication skills
• Strong background in manufacturing

• Bachelor’s Degree in engineering, systems management, measurements, or related sciences field or at least 5 years’ quality management systems experience

• Experience managing or maintaining QMS compliance in a regulated industry such as ISO 9001 or cGMP
• Internal and/or external lead auditing experience for ISO 9001 or ISO 13485 standards
• Project management skills

• Compensation:
  The salary range is tied to the market for similarly benchmarked roles. The…