QA Lead, Medical Devices — Inspection & Compliance

Innovative Health LLC; Scottsdale (AZ); Sur place; USD 75 000 - 95 000; Plein temps

Résumé du poste

Innovative Health LLC is seeking a Quality Supervisor to plan and oversee reprocessing activities within the Quality Control department. You will ensure compliance with quality systems and regulatory requirements across all stages of inspections and materials handling.

The role focuses on staffing, training, KPIs, and overtime management, while driving continuous improvement initiatives and supporting audits. Experience with 21 CFR 820, ISO 13485, and ERP systems is essential.

Qualifications

• Bachelor's Degree in Life Science preferred or Associate with 2–5 years quality experience in medical devices.
• Strong supervisory experience (1–2 years).
• Experience with 21 CFR 820, ISO 13485 and Quality Systems is desirable.

Responsabilités

• Plans and supervises reprocessing QC activities in compliance with quality systems and regulatory requirements.
• Manages daily QC needs: staff tasks, training, productivity, KPIs, overtime approvals.
• Creates and enforces procedures for inspection, testing, identification, handling and storage of reprocessed products and materials.
• Drives quality improvement initiatives (e.g., Kaizen, Six Sigma) to enhance product line performance.
• Supports internal and external audits and reports quality trends and losses to management.
• Oversees inspections across incoming, in-process, finished goods and post-sterilization stages.
• Ensures proper labeling, storage, and handling to prevent mix-ups throughout the facility.
• Maintains MRB processes and material status updates in the ERP system.
• Establishes metrics (process capability, control charts) to monitor system effectiveness.

Connaissances

Quality supervision

Regulatory compliance

Process improvement

Documentation & records

Formation

Bachelor's Degree in Life Science

Outils

J.D. Edwards ERP

Description du poste

Innovative Health LLC is seeking a Quality Supervisor to plan and oversee reprocessing activities within the Quality Control department. You will ensure compliance with quality systems and regulatory requirements across all stages of inspections and materials handling.

The role focuses on staffing, training, KPIs, and overtime management, while driving continuous improvement initiatives and supporting audits. Experience with 21 CFR 820, ISO 13485, and ERP systems is essential.