Senior Packaging Compliance Engineer

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Senior Packaging Compliance Engineer

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    Senior Packaging Compliance Engineer
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    Direct Hire
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 Senior Packaging Compliance Engineer will be frequently assigned leadership responsibility for entire projects including:


  • Perform Gap Analysis of existing documents (Ship Testing, Aging studies, and process validations) to latest standards such as ISO-11607 Part 1 and Part 2.
  • Lead Remediation activities to bring existing DHF/Tech files to State of the Art compliance.
  • Perform Gap Assessment between latest standards (such as ISO, ASTM, ISTA) to last revision.
  • Utilize quality and regulatory compliance expertise to support regulatory body audits, draft technical responses to ensure compliance to latest industry practices.
  • Project Management: Lead project meetings, deliverables and provide updates to management.
  • Provide technical expertise and project support to new product development teams by consulting within areas of packaging materials and equipment.
  • Identifying and supporting the purchasing of new packaging equipment.
  • Preparation of capital expenditure requests, drawings and specifications for new processes and equipment.
  • Assisting in artwork creation and revisions for product packaging.
  • Performing packaging validation testing to support new product development and sustaining.
  • Testing new packaging methods and processes using various testing apparatus in qualification of packaging changes 


Must Have:   Minimum Requirements


  • BS Degree in Packaging Science, Mechanical Engineering or equivalent with minimum of 5-7 years’ combined experience in Packaging and Quality Engineering within Medical devices.
  • Proven track record preparing written policies, procedures, proposals and reports.
  • Knowledge of ISO, ASTM and ISTA package test methods is required.
  • Basic understanding of Medical Device Regulation (MDR) is required.
  • Knowledge of Microsoft Office programs is required. 
  • Strong team and interpersonal skills


Nice to Have:  Preferred


  • Medical device, pharmaceutical or related industry preferred.
  • Strong leadership skills.  Ability to mentor and coach others
  • Broad knowledge of Mechanical/Manufacturing Engineering
  • CAD programming knowledge.
  •  Knowledge of TOPS/CAPE required


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