Sr. Quality Specialist

Job Description:

This position is responsible for compliance to the non-conformance process, and to applicable Medical Device and IVD regulations and requirements by serving as a subject matter expert in providing guidance to NC owners, and working closely with Material Review Board (MRB) members in the administration of NC activities and the rigorous assessment of NC documentation.

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.
• Provide guidance in interpreting governmental regulations, agency guidelines and Client internal policies in general and specific to NC to assure compliance.
• Support internal and external audits and inspections for NC records and processes and other roles as needed.
• Perform other related duties as assigned.
  
  

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
• Project management skills
• CAPA documentation systems experience (e.g. CATSWeb, MasterControl, Trackwise,, etc.)
• Experience reviewing CAPA, complaint, nonconformance documentation (preferably as an independent reviewer)
• Strong written and verbal communication skills
• Ability to educate people in the CAPA program
• Experience with quality tools and process improvement techniques
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Strong analytical and decision making skills
• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and CAPA requirements in general
  
  

Exact Schedule - 9am-5pm, M-F