Responsibilities include the following:
· Leads successful validations of packaging systems for medical devices
· Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
· Lead project meetings and provide updates to management
· Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.
· Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.
· Leads successful validation of packaging systems for medical devices
· Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.
· Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.
· Lead project meetings and provide updates to management.
· Assist in labeling development process.
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Job Disclaimer:
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
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The Company will consider qualified applicants with arrest and conviction records.
Pay: $48.00 - $60.00 per hour
Benefits:
- Dental insurance
- Health insurance
Work Location: In person
