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Company

Original Job Post

VARITE INC · 2 days ago

Sr. Quality Specialist

Los Angeles, CA

Contract

Onsite

Senior Level

$35/hr - $40/hr

3+ years exp

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Responsibilities

Provide continuous and rigorous assessment of NC activities and documentation to assure compliance with the Quality Management 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's 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.

Qualification

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CAPA experienceMedical device experiencePharmaceutical experienceIVD experienceRegulated environment experienceCAPA documentation systems experienceReviewing documentation experienceQuality tools experienceProcess improvement techniquesRoot cause investigation knowledgeCorrective action planning knowledgePreventive action planning knowledgeVerification of effectiveness techniques knowledgeFDA regulations knowledgeISO 13485 knowledgeCAPA requirements knowledgeInfluence managementProject management written communication verbal communication educate analyticalDecision-making

Required

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

Preferred

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