Onsite Quality Compliance Lead - Medical Devices

Viant Medical; Vega Baja (PR); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision benefits

Company-paid life insurance

Generous paid time off

401k Plan with Company Match

Tuition Reimbursement

Zusammenfassung

Viant Medical is seeking a Quality Compliance Supervisor to lead the Document Control Team and oversee quality systems, CAPA, audits, training, and environmental control at the site. You will ensure documentation accuracy, regulatory alignment, and robust training programs to meet customer and FDA/ISO requirements.

The role requires expertise in sterilization, microbiology, and control of quality system processes, with onsite responsibilities and collaboration with HR for training and job coding.

Qualifikationen

• BS/BA in Sciences, Microbiology or Technical Discipline
• Certified Lead Auditor
• Knowledge of FDA 21 CFR 820 QSR, ISO13485 Medical Device Standard, 21 CFR Part 4 Combination Products, 21CFR Part 11 electronic records and signature, ISO14971 Risk Assessment

Aufgaben

• Maintain effectiveness of the Plant Quality Management System and document control.

Kenntnisse

Auditing

CAPA management

Communication

Customer liaison

Independence & teamwork

MS Office

Master Control

IQMS

Ausbildung

BS/BA in Sciences or Microbiology

Certified Lead Auditor

FDA/ISO knowledge (QSR, ISO13485)

Tools

Master Control

IQMS

Jobbeschreibung

Viant Medical is seeking a Quality Compliance Supervisor to lead the Document Control Team and oversee quality systems, CAPA, audits, training, and environmental control at the site. You will ensure documentation accuracy, regulatory alignment, and robust training programs to meet customer and FDA/ISO requirements.

The role requires expertise in sterilization, microbiology, and control of quality system processes, with onsite responsibilities and collaboration with HR for training and job coding.