FDS LLC
Piscataway, NJ
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Job Description :
Job Title Packaging Engineer- US / GC only
Relevant Experience
A minimum B.S. in Engineering with 4+ years of related experience in product packaging.
or
A minimum M.S. in Engineering with 2+ years of related experience in product packaging.

Technical/Functional Skills:
The purpose of this role is to establish and maintain quality assurance standards which adhere to Quality System Requirements (QSR) and ISO regulations to ensure products and services are provided to customer requirements. Responsible for the quality and regulatory compliance of products manufactured at Internal and External Manufacturers.

Strong engineering skills with working knowledge of product design, design verification, and product and process validation activities
Strong data analysis skills. Ability to use problem solving techniques including root cause analysis and cause and effect analysis, Statistical techniques and methods.
Product Packaging experience
Knowledge of ISO quality standards is required; Familiarity with FDA 21 CFR 820 and ISO 13485 & ISO 14971 is a plus
Use Statistical tools to maintain and analyze metrics
Work closely with Quality Control, Quality Engineering, Product and Manufacturing Engineering departments

The qualified candidate for this hands-on position should be able to use Engineering principles, tools, and practices to determine root cause of component failure and develop and implement corrective/preventive actions that are aligned with the overall business and quality vision. The individual must be capable of working independently and in a team setting supporting the resolution of component failures and conducting required statistical analysis.
Experience Required 4-6 years
Roles & Responsibilities The primary responsibilities of this role include

Designs and develops sterile packaging systems with limited supervision.
Coordinates and monitors packaging projects and programs from inception through implementation
Establishes appropriate project schedules and prepares project reports periodically to outline progress
Ensure all packaging projects are compliant with regulatory and corporate guidelines
Communicates effectively with cross functional teams, such as R&D, Marketing, Clinical, Regulatory Affairs, Quality Assurance, Purchasing, and Operations
Develops protocols and reports for packaging feasibility studies and Design Verification for new products
Prepares reports/documentation using good documentation practices and effectively communicates results cross-functionally and vertically within the organization
Creates and reviews Engineering Change Requests for packaging for design changes
Effectively works with manufacturing process teams to implement new design changes quickly and effectively
Assists in the development of standardized test procedures, polices, and standards
Leads or assists with Corrective and Preventative Actions (CAPA) projects as necessary
Duration of assignment (in Months) 12 months
Work Location (State, City and Zip) Plymouth, MN,
Key words to search in resume Packaging, Process Validation, Verification
Prescreening Questionnaire Medical Device Knowledge or industry experience


Client : Direct Client
             

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