Senior Packaging Compliance Engineer

1970-01-01Davis Companieshttp://www.daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
Search Jobs

Senior Packaging Compliance Engineer

  • Specialty:

    Engineering
    • City:

      Woburn
    • State:

      MA
    • 02110
  • Assignment Type:

    Direct Hire
  • Job Id:

    50743

Description

 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
     

#GDMAENG #MON

Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

Loading...