Senior Quality Compliance Auditor in Elkton, MD at Integrated Resources, Inc

Date Posted: 1/1/2020

Job Snapshot

Job Description

Senior Quality Compliance Auditor
Production floor auditing experience is Must
Job Summary:
This position is responsible for assisting with the implementation of best practices to optimize quality, efficiency & productivity in systems throughout client and other client facilities. This position is responsible for the execution of Internal Audit activities and administration of the Internal Audit process in accordance with Company procedures.

This position will interface with individuals at all levels of the organization to conduct audits at specified intervals report audit findings, facilitate and monitor the life-cycle of audit findings until completion. This position promotes continuous improvement of systems, products, and services, by managing and supporting global external regulatory compliance inspections, responses, and action implementation follow up.

This position is responsible for analyzing and monitoring quality data to identify potential issues and implement necessary actions to mitigate compliance and product risks.

This position will provide guidance to assist in the development, implementation, and maintenance of the Quality Management Systems to ensure the organization functions effectively and efficiently in order to ensure a high level of Regulatory Compliance and to achieve Company goals, objectives, and policies as well as satisfy customer requirements.

Job Details:
  1. Leads/Assists 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 within specified timeframes and generate audit corrective action requests as applicable.
  2. Monitor internal audit non-conformances, perform trend analyses, and present findings.
  3. Contribute to the development and improvement of audit program metrics.
  4. Provide support for the Business' internal and external audit compliance strategies.
  5. Implement changes to the Quality System procedures s as needed to maintain compliance, improve effectiveness and efficiency.
  6. Facilitate the Internal Audit Program.
  7. Interface with FDA and third-party auditors during inspections.
  8. Monitor and remain current with internal company procedures/policies, International QS standards and federal regulations.
  9. Participate in process improvement activities to continuously improve process effectiveness.
  10. Other activities as assigned by management
Position Requirements:
  • Requires at least 5 years work experience in Quality/Compliance within a regulated industry.
  • Significant work experience in Quality System Auditing (ASQ certification or ISO Lead Audit certification is required). 13485 is the ideal (Med Device)
  • Knowledge of national and international regulations applicable to medical devices including: FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, MDD (European) requirements, etc.
  • Apply effective time management, critical thinking, problem solving and collaborative approaches to improving internal audit program
  • Excellent communication skills and the ability to express ideas both orally and in written form.
  • Well organized and accustomed to maintaining quality/cGMP compliant records
  • Ability to work with team members across functions/departments.
  • Ability to effectively present information to top management and team members.
  • Ability to identify priorities and function independently required.
  • Ability to analyze situations thoroughly, identify potential problems, find and implement effective solutions.
Background Experience
  • BS in Engineering or Science (Life Sciences preferred)
  • Computer skills, including proficiency with Word, Excel, and PowerPoint
  • Certified Quality Auditor (CQA) certification required and/or ISO 13485 lead auditor certification
  • Experienced lead auditor for medical device industry
  • Demonstrated understanding of industry regulations, including detailed knowledge of FDA QMS and ISO 13485