4337 Packaging Engineer

Location: Plymouth, MN, United States
Date Posted: 07-26-2017
Job Title Packaging Engineer
Relevant Experience
(in Yrs)
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. 
  • Hands-on quality supplier quality visits and dealing directly with supplier processes, validation of those processes and their quality standards
  • Manufacturing process management & product validation against intended product use and requirement stipulations
  • Knowledge of ISO quality standards is required; Familiarity with FDA 21 CFR 820 and ISO 13485 & ISO 14971 is a plus
  • Develop supplier non-conformance reports and corrective action reports
  • Use Statistical tools to maintain and analyze metrics
  • Apply assessment and Gap Analysis techniques against requirement stipulations to improve manufacturing process, identifying those gaps and helping to close them
  • Train, mentor and coordinate Supplier Quality staff
  • Work closely with Quality Control, Quality Engineering, Complaint handling, 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
Generic Managerial Skills  
Education A minimum B.S. in Engineering with 6+ years of related experience in supplier quality control/assurance.
or
A minimum M.S. in Engineering with 4+ years of related experience in supplier quality control/assurance.
 
Term Fulltime permanent positiion
Prescreening Questionnaire Medical Device Knowledge or industry experience

If you bring willingness, flexibility and a desire to impress please apply now.
Technical Recruiter: Sajita Sreerangam
Email:
sajita@reqroute.com
Phone: 4087574337
Companies across U.S. have engaged ReqRoute, Inc to deliver skilled, dedicated IT professionals. Recruiting is our passion and we support Fortune 1000 companies with their hiring needs. We always seek to deliver competitive and sought-after career opportunities to our potential consultants and employees. We invite you to review the position requirements and apply today if your skills match our needs.  
 
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. (www.reqroute.com)
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