Senior Quality Compliance Specialist/Lead Auditor

Location: San Jose, CA

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Senior Quality Compliance Specialist/Lead Auditor

Job Locations US-CA-San Jose
Job ID
2021-1388
# of Openings
1
Posted Date
5 months ago(5/17/2021 4:45 PM)
Category
Quality/Regulatory Affairs

Overview

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.

Responsibilities

  • Ensure all CAPA records are established, maintained, documented, are closed in a timely manner and according to QMS procedures.
  • Assist CAPA owners on investigations, action plans, and verification and/or validation activities.
  • Assist owners in root cause analysis.
  • Chair the monthly CAPA management meeting and provides metrics for CAPA status.
  • Gather and analyze metrics to measure effectiveness and makes recommendations to improve the CAPA program.
  • Coordinates the review of CAPAs to determine their effectiveness.
  • Ensure on-time completion of CAPAs.
  • Identify and execute opportunities for continuous improvement (Lean).
  • Interface with FDA and third party auditors during inspections.
  • Oversee the internal audit program and the audit program corrective actions.
  • Ensure that all corrective actions from internal and external audits are effective and verified.
  • Act as liaison with regulatory agencies to obtain information related to product standards and regulations.
  • Lead 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.

Qualifications

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 

EQUAL OPPORTUNITY EMPLOYER - DISABILITY AND VETERANS

 

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