QMS Specialist

About the Role As a QMS Specialist, you will support the implementation, maintenance, certification, and continuous improvement of the site Quality Management System to ensure alignment with applicable standards, customer expectations, and regulatory requirements. This role will be key in driving audit readiness, CAPA effectiveness, documentation control, and quality systems integration with manufacturing and business processes. What You'll Do

• Support the implementation, maintenance, certification, and continuous improvement of the site Quality Management System.
• Lead, coordinate, or support internal, customer, supplier, certification, and regulatory audits, ensuring timely follow-up on findings.
• Drive corrective and preventive actions, including root cause analysis and verification of effectiveness.
• Maintain and control QMS documentation and records through document control systems or equivalent platforms.
• Partner with Operations, Engineering, EHS, and Supply Chain to ensure QMS requirements are integrated into site processes.
• Support APQP, PPAP, FMEA, Control Plans, MSA, process validation, and other Quality Core Tools activities.
• Monitor site quality metrics and support continuous improvement initiatives focused on reducing defects, variation, and customer concerns.
• Train and coach employees on QMS requirements, audit readiness, and quality best practices.
• Coordinate management review and certification activities with key stakeholders.
• Support compliance with applicable regulatory and customer requirements, including customer complaints and returns processes. What We're Looking For
• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related discipline.
• Experience in quality engineering, Quality Management Systems, or related quality roles.
• Familiarity with quality standards and audit practices such as ISO 9001, IATF 16949, ISO 13485, AS9100, ISO 19011, or similar standards.
• Knowledge of Quality Core Tools such as APQP, PPAP, FMEA, SPC, MSA, Control Plans, 8D, or root cause analysis.
• Effective communication skills in English, with the ability to facilitate discussions, provide training, and work with cross-functional stakeholders. What Will Put You Ahead
• Auditor certification or lead auditor training in ISO 9001, IATF 16949, ISO 13485, or related standards.
• Experience in regulated industries such as medical device, automotive, or aerospace.