Senior Quality Specialist

Title: Sr. Quality Specialist

Location: West Hills, CA

Duration: 6 Months

Pay: $35 - $40 ph.

Position Responsibilities:

• Provide continuous and rigorous assessment of NC activities and documentation to assure compliance with the Quality Managment system, FDA regulations, ISO 13485, and Medical Device and IVD requirements through the review of NC records at critical phases.
• Provide guidance, support and mentorship to NC process owners regarding the NC process, best practices, record content, and software tools.
• Support MRB and senior leadership with metrics and reporting on critical aspects regarding the health of the NC process.
• Participate and coordinate MRB activities and perform walk through internal audits throughout the site.
• Support the continuous improvement of procedures, software, and training programs.
• Support internal and external audits and inspections for NC records and processes and other roles as needed.

Basic Qualifications:

• Bachelor's degree and 3+ years or Master's degree with 1+ years in a quality, manufacturing, or leadership role (preferably in Quality Managment Systems)

Desired/Preferred Qualifications:

• Experience working with CAPA, complaints, and nonconformances
• Experience in medical device, pharmaceutical, IVD and/or a comparable regulated environment
• Influence management skills; ability to work constructively across all functions of the organization as well as with external customers, notified bodies, regulatory agencies, and competent authorities
• CAPA documentation systems experience (e.g. CATSWeb, MasterControl, TrackWise,, etc.)
• Experience reviewing CAPA, complaint, nonconformance documentation (preferably as an independent reviewer)
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and CAPA requirements in general