To enhance our Team of Global Compliance, we are looking for:
Senior Compliance Specialist
to lead assigned Quality System processes.
Your Responsibilities include and are not limited to:
- Leading internal audits and supplier audits,
- Leading the readiness program for ISO Registration audits, FDA Inspections and customer audits
- Preparing submissions and responses to FDA and ISO Registrars
- Acting as the primary compliance contact for site departments, business units, and corporate functions
- Acting as a subject matter expert for the Quality Systems and Compliance programs.
- Ensuring the site’s quality system development, effective maintenance and continued compliance with business unit requirements, medical device regulations and standards (i.e., U.S. – FDA, ISO 13485, Anvisa)
- Supporting the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.
- Performing all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements
What will you bring:
- Educational background in one (or more) of the following fields: Quality, Regulatory, Engineering, Business or Life Sciences
- 6 + years of industry experience within Quality and/or Regulatory
- Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
- Experience with compliance assessments, gap assessments and risk assessments.
- Experience with program change management practices, lean or six sigma, program and system integration effort.