SUMMARY OF POSITION:

This position is responsible for providing Quality oversight of New Product Introduction (NPI), Product Remediation, and Continuous Improvement projects, having major impact on Quality performance and the company's ability to market products in accordance with US and international regulations.

YOUR ROLE

• Perform duties as the Quality representative for New Product Introduction (NPI) and/or Product remediation projects. 
• Ensure compliance of the Design History File (DHF) with applicable procedures, standards, and regulations.
• Ensure that projects and new products meet applicable QMS, statutory, and regulatory requirements.
• Define and track product and process quality requirements throughout the projects.
• Provide support and Quality guidance to the Project team, specifically on topics such as:
  • Product design process
  • Risk Management
  • Design verification and validation strategies
  • Process validation
  • Computerized System Validation (CSV)
  • Supplier selection
  • Usability Engineering
  • Design transfer
• Process engineering change orders related to projects in collaboration with Regulatory Affairs, Quality, Manufacturing, Procurement, and D&E Partners.
• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.

• Carry out other duties, special assignments and projects as assigned by the Site Quality Manager.

   

YOUR BACKGROUND

• Bachelor's degree in a scientific or engineering discipline, or equivalent combination of education, training, and experience. MBA or master's degree in a STEM field preferred.

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``` - Minimum of four (4) years of experience in quality systems for Medical Device manufacturing and/or design. - Minimum of two (2) years of experience in Project Management and New Product Introduction. - Experienced in the creation and implementation of SOPs and Work Instructions. - Knowledgeable of standards and regulations applicable to medical devices: FDA 21CFR820 & ISO 13485: 2016, MDSAP, & EU Medical Device Regulation (MDR). - Quality professional certification, such as ASQ CSSGB, CSSBB, CQA, CRE, and/or CQE preferred. - Project Management Professional (PMP) certification preferred. - Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint, & Visio) and Minitab.