ZOLL Circulation, Inc.

Quality Compliance Specialist/Lead Auditor

Job Locations US-CA-San Jose
Posted Date 1 month ago(2/16/2018 5:05 PM)
Job ID
# of Openings
Quality Assurance


General Summary:

The Senior Quality Compliance Specialist/Lead Auditor is responsible for ensuring all Corrective Action/Preventive Action (CAPA) and Internal Audit activities are compliant to ZOLL’s Quality Management System (QMS). This individual will be responsible to identify, analyze, investigate, monitor, and document patterns and trends in post market surveillance data as part of the CAPA and Internal Audit systems. Communicate to Management, QA, R&D, Operations and other departments regarding product performance, quality compliance and system metrics.


Essential Functions:

  • 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.


Skill Requirements:

  • 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.



Education/Training/Experience Requirements:

  • 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



Language Ability:

Ability to read, analyze and interpret complex quality documents.


Math Ability:

Ability to apply and understand advanced mathematical operations.


Reasoning Ability:

Ability to problem solve.


Computer Skills:

Working knowledge of desktop computer and software programs.


Certificates and Licenses:

Auditor certification required.


Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.


Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.


Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is also required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.


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