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Quality Compliance Specialist/Lead Auditor

Zoll Medical Corporation

SAN JOSE CA 95115

Quality Compliance Specialist/Lead Auditor



Tracking Code


1744-547


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


Full-Time/Regular


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