Senior QMS & CAPA Specialist — Quality Systems Leader

Teleflex; Olive Branch (MS); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Teleflex is seeking a Quality Management Systems Specialist 3 to support development and maintenance of quality programs ensuring compliance with FDA, ISO, and other standards at the North American Distribution Center. You will lead document control, CAPA, metrics, internal audits, and training, partnering with Regulatory and technical teams to drive continual improvement and operational excellence across the site.

Travel required up to 10%.

Qualifikationen

• Bachelor’s degree in business, sciences, quality management-related field, or equivalent professional experience
• 5+ years of relevant experience in a medical device environment with Quality Management Systems
• Ability to work in a cross-functional team, multitask, and meet deadlines
• Experience with regulatory inspections/audits
• Experience and knowledge of risk management and CAPA systems
• Certifications (ASQ CQA/ASQ CLMDA / Exemplar Global/ AAMI) preferred
• ISO 13485 Lead Auditor Training, preferred

Aufgaben

• Manage the document control lifecycle of all QMS documents
• Establish, monitor, and respond to metrics on the efficacy of the document management system
• Develop, monitor, and improve CAPA processes
• Provide training and mentorship to NC owners
• Support management review and generate QMS metrics
• Lead site audits and inspections with regulators and suppliers
• Identify opportunities to improve quality system processes
• Collaborate with Regulatory and technical teams to ensure compliance and success

Kenntnisse

Cross-functional teamwork

Regulatory audits

CAPA management

Data analysis

Verbal & written communication

Ausbildung

Bachelor's degree in business/sciences/quality management or equivalent

Tools

MS Word

Excel

PowerPoint

Jobbeschreibung

Teleflex is seeking a Quality Management Systems Specialist 3 to support development and maintenance of quality programs ensuring compliance with FDA, ISO, and other standards at the North American Distribution Center. You will lead document control, CAPA, metrics, internal audits, and training, partnering with Regulatory and technical teams to drive continual improvement and operational excellence across the site.

Travel required up to 10%.