- Opportunity to join a business that is changing the medical device landscape
- Excellent company culture for their employees
About Our Client
Our latest client is an FDA-approved OEM medical device company with significant operations across the globe.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Essential Duties & Responsibilities
- Provide SME level support of the risk management function across the organization.
- Provide recommendations for procedure updates to support EU MDR compliance
- Work with SME's to map strategy to move towards an automated Risk-based trending system
- Work with SME's to create framework for Risk-based dashboards to be used for more real-time decision making and management reporting
- Own procedures associated with Device Risk Management activities.
- Provide training and coaching to all global medical device sites as to the execution of the Risk Management process.
- Own mechanism used to gauge the health of the risk management system through review of data and metrics and communicate to the Process Owner and Quality System SPAs
- Identify inefficiencies in system of record (e.g. Agile) related to Risk Management and drive improvements to the system of record
- Own deliverables and commitments associated directly with the risk management process.
- Provide guidance as to the performance of development of products or the investigation of Nonconformities or CAPAs as it relates to Risk Management.
- Perform other related duties as assigned or required.
- Work on special projects as they arise.
The Successful Applicant
Knowledge, Skills & Qualifications
- Company leader for Risk Management with proven ability to own direct management issues and advise on issues escalated to higher management
- Has deep knowledge of best practices related to Risk Management deployment procedurally, within associated documentation systems and with key stakeholders
- Has subject matter expertise on ISO 14971 and EU Medical Device Regulation (MDR) 2017/745
- Demonstrated knowledge of Risk Management fundamentals and working knowledge of both Quality Management Systems and Risk Management linkages to other Quality System processes (Design Controls, CAPA, Complaints, Document Control, etc.)
- Working knowledge of Product Lifecycle Management (PLM) system approach to house Risk Management documentation and associate with the respective Device Master Record (DMR)
- Demonstrated ability to develop database management strategies and metrics across multiple platforms
Education and Experience
- Bachelor's degree in Engineering Systems, Mechanical or Electrical from an accredited college or university is required
- Master's Degree is preferred
- ASQ-CMQ/QE Certification desired, not required
- Minimum of 10 years of experience required
What's on Offer
- Competitive base salary, depending on project experience and skills
- Growth company- this organization is expecting to double its size over the next few years
- Great benefits package - annual bonus, matching 401k, medical, dental, life.
- Comprehensive benefits package (100% Coverage for Individual & Dependents)