Job Title: Risk Management Project Manager I / Specialist
Job Location: Remote
Duration: 9-12+ Months
RESPONSIBILITIES:
Create, review and maintain risk management files.
Lead cross functional teams in the creation and maintenance of risk analysis documents.
Ensure that product development projects and changes to existing products and processes are incorporated into the risk management process.
Support the continuous improvement to the Quality Management System, with a specialty focus on risk management and associated processes.
Act as the lead team member in establishing, communicating and mitigating risks.
Review design history files and technical files for conformance to applicable requirements.
Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
Provides leadership in the understanding of FDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing, including hardware, software, and bioassay systems.
BASIC QUALIFICATIONS | EDUCATION:
Bachelors' degree (B.S.) in a Science related field, or equivalent combination of
education and experience
1-3 years related experience and/or training in a Quality and/or Development Position.
Significant experience in risk management throughout the product lifecycle, including a
strong working knowledge of ISO 14971
PREFERRED QUALIFICATIONS:
Experience supporting ISO 13485 inspections and FDA inspections.
Experience in a multi-site development environment.
Experience in compliance management within a rapid-growth, dynamic organization.
