QA and Regulatory Affairs Manager

  • Jobot
  • Waco, TX, USA
  • Aug 01, 2020
Full time Government

Job Description

This Jobot Job is hosted by: Forrest Mack
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $55,000 - $75,000

A bit about us:

Our mission is to enable contamination control professionals to improve particle control in clean rooms by solving surface contamination challenges.

Why join us?

Benefits

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off


Job Details

Summary:

QA and Regulatory Affairs Manager have primary responsibility for our ISO13485/cGMP compliant quality system for Foamtec's regulated businesses, including Medical Device, Pharmaceutical, and Life Sciences. Will have direct responsibility for regulatory reporting and audits with the FDA, certifying bodies, customers and suppliers. The qualified candidate will have prior experience as a QMR with documentation and project management knowledge within an international company.

Requirements:

Bachelor's degree in science
  • 5+ years of working experience in regulatory and/or product development/product manufacturing.
  • Working knowledge of US FDA medical device for manufacturing (cGMP & FDA 21 CFR 820) and distribution.
  • Previous experience as a QMR in any quality system preferred
  • High level of organization skills required
  • Ability to work independently in a fast-paced, high-pressure environment is required
  • Advanced knowledge of Microsoft Excel, Word, and Outlook
  • Advanced communication and problem-solving skills

Responsibilities:

  • QMR for entire ISO13485/cGMP Quality System
  • Maintain and update the quality system (ISO13485 & 21 CFR 820) as required
  • Primary internal auditor and trainer
  • A lead representative for regulatory, certifying body and customer audits
  • Maintain files of Finished product specifications, coordinate approvals with sales and customers
  • Create, distribute and process procedures to maintain compliance to ISO 9001, ISO 13485, and cGMP
  • Provide Certificates of Compliance for custom products, and technical documents such as technical data sheets as requested by Sales Team and customers
  • Submit required FDA related documents and reports on imported devices and DMR's as required
  • Coordinate Quality System with counterparts at facilities in Thailand
  • Involve in incoming QA inspections and maintenance of the MRB area.
  • Other projects as assigned involving QA/QC and New Product Development
  • Reporting to the top management on the performance of the Quality Management System including needs assessment.


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