Senior Packaging Compliance Engineer
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Senior Packaging Compliance Engineer
Title:Senior Packaging Compliance Engineer
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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