- 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.
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