Medical Device Sterile Packaging Project Manager
New Jersey, Bergen-Passaic
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Medical Device Sterile Packaging Project Manager for a 8 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Provide Packaging Subject Matter Expertise for Sterile Packaging of Medical Device Implants.
Perform remediation of existing sterile packaging and cleaning for Medical Device implants to comply with ISO11607-1 and ISO11607-2 (Packaging For Terminally Sterilized Medical Devices).
Work closely with all cross functions in the business, especially core project teams, marketing, regulatory, quality and operations to support the business objectives.
Lead the post launch assess phase activities of all product packaging design solutions for products.
Provide technical support to both the Quality Assurance and Regulatory teams to help investigate and recommend solutions to any package design related issues and the completion of technical assessments/SofHA s where applicable.
Own all package design related NCR/CAPA s for the Packaging Group and ensure timely closure of all issues in line with procedure guidelines.
Conduct VOC (voice of the customer) for packaging and transfer it into appropriate action with regards to packaging design ensuring proactive and satisfactory closure with the customer
Provide technical support to Packaging Operations to help troubleshoot, investigate, and recommend solutions to any package related issues.
Provide technical support to the Supply Chain team on any package related supplier issues or re-sourcing activities.
Determine, coordinate and execute physical package testing to ensure product and package integrity.
Write and perform test protocols for evaluations and validation.
Interface with the Global PSE Packaging Group and other Advanced Operations team members both locally and globally, Quality Assurance / Regulatory and Operations Teams to ensure equivalency of approach in Equipment, Processes and Validation techniques.
Maintain an overview of state-of-the-art technologies within medical device packaging through understanding of technology, clinical practice, regulatory environment and competitive and intellectual property landscape assessment.
All other duties as assigned.