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Senior Consultant at Mason Alexander - Medtech Contract
Our leading client has an exciting opportunity for a Senior Packaging Engineer on a 12-month contract with very competitive hourly rates.
Job Responsibilities and Experience:
* Ability to translate the needs of vascular medical devices into packaging solutions in compliance with ISO 11607-1, ISO 11607-2, FDA, and EU MDR regulations.
* Knowledge of packaging material compatibility and limitations with common sterilization methods.
* Ability to collaborate closely with suppliers to ensure purchased components are compatible with internal requirements.
* Knowledge of bio-compatibility, endotoxin and sterility requirements.
* Ability to collaborate closely with external test labs to ensure testing is conducted to internal and external requirements.
* Prepare detailed technical documentation, including packaging specifications, reports, and validation records, in alignment with Quality Management System requirements.
* Ability to work closely with cross-functional teams, including Product Development, NPI, Regulatory, and Quality Assurance, to align packaging solutions with overall project goals.
* Knowledge of equipment and process development.
* Experience in packaging equipment validation including IQ/OQ/PQ.
* Act as a technical packaging resource for troubleshooting and process improvements.
* Strong analytical and problem-solving abilities.
* Excellent communication and documentation skills.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Staffing and Recruiting and Medical Equipment Manufacturing
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