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Quality Compliance Specialist/Lead Auditor

Zoll Medical Corporation


Quality Compliance Specialist/Lead Auditor

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Job Description

+ Ensures all CAPA records are established, maintained, documented, are closed in a timely manner and according to QMS procedures.

+ Assists CAPA owners on investigations, action plans, and verification and/or validation activities.

+ Assists owners in root cause analysis.

+ Chairs the monthly CAPA management meeting and provides metrics for CAPA status.

+ Gathers and analyzes metrics to measure effectiveness and makes recommendations to improve the CAPA program.

+ Coordinates the review of CAPAs to determine their effectiveness.

+ Ensures on-time completion of CAPAs.

+ Identifies and executes opportunities for continuous improvement (Lean).

+ Interfaces with FDA and third party auditors during inspections.

+ Oversees the internal audit program and the audit program corrective actions.

+ Ensures that all corrective actions from internal and external audits are effective and verified.

+ Acts as liaison with regulatory agencies to obtain information related to product standards and regulations.

+ Leads quality system audits to ensure the QMS operates in a state of compliance and continuous improvement

+ Prepare audit reports and conduct audit briefings upon completion of audits.

+ Document audit reports within specified time frames and generate audit corrective action requests as applicable

+ Follow, interpret and develop written Policies and Standard Operating Procedures (SOP's).

+ Monitor internal audit non-conformances, perform trend analyses, and present findings

+ Contribute to the development and improvement of audit program metrics

+ Report systemic quality system issues through the analysis of quality data such as CAPAs, complaints, MDR/Vigilance reports, audit reports and other relevant data

+ Participate in process improvement activities to continuously improve process effectiveness.

+ Review completed quality records to ensure completeness and adequacy. Discuss any encountered issues with Quality Management.

+ Other activities as assigned by QA management.

Required Skills

+ Ability to work under minimal supervision and have excellent time management skills.

+ Possess good interpersonal and interview skills, a strong attention to detail, coupled with an uncompromising dedication to ethical, professional behavior.

+ Ability to interpret requirements to generate audit checklists in support of company and regulatory requirements.

+ Must be able to interpret and apply domestic and international regulations.

+ Possess proven negotiation and conflict resolution skills.

+ Excellent analytical, prioritization and multitasking skills.

+ Ability to work with team members across functions/departments.

+ Ability to effectively present information to top management and team members.

+ Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

+ Demonstrates accuracy and thoroughness; applies feedback to improve performance.

+ Required Experience

+ BS in Science or Engineering. Equivalent QA experience considered.

+ Experience using Microsoft Word, Excel.

+ Certified Quality Auditor (CQA) certification required and/or ISO 13485:2016 lead auditor certification

+ Experienced lead auditor for medical device industry

+ Demonstrated understanding of industry regulations, including detailed knowledge of FDA QMS and ISO 13485

Job Location

San Jose, California, United States

Position Type


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