Search
  • Oscar Garcia

New Job Opportunity: QA Consultant / Site QA Leader (Full Time)


Responsibilities

Accountable for compliance to FDA 21 CFR Part 820, ISO 13485:2016 and other applicable regulatory requirements for the site operations, including, but not limited to:

  • Ensure execution and compliance of all QMS processes, including training, resource management, production controls, equipment control, non-conformance, CAPAs, audits, acceptance activities, etc.

  • Support the investigation of technical problems and evaluate & implement solutions.

  • Serving as primary contact in any audit by a regulatory authority and lead all audit communications.

  • Engage team in day to day activities, specially related to site operations and improvement projects.

  • Reporting on the performance and effectiveness of the quality system and any need for improvement to the executive management for review.

Education, Experience and Background Requirements

  • 7+ years of experience in a quality role at a medical device company.

  • Background/education in engineering/science or related field.

Training and Skills Requirements

  • Strong communication skills and experience working in small teams.

  • Experience with FDA 21 CFR Part 820, ISO 13485:2016.

Apply

  • Send us a copy of your resume to admin@qesmedical.com with the subject “QA Consultant / Site QA Leader (Full Time)”

  • Write a brief description of why you think you are a good fit for this role.

33 views0 comments

Recent Posts

See All

Responsibilities Actively execute quality assurance in design development, including but not limited to: Support design control deliverables. Author verification and validation protocols and reports.