NPI Quality Lead — Medical Devices & Biopharma

NPI Quality Engineer (Medical Device / Biopharma)

Must be authorized to work. No relocation US Citizen or Green Card holder

Join a growing medical device organization focused on quality, compliance, and continuous improvement. This role will play a key part in ensuring externally sourced materials, components, and services meet FDA, ISO, and internal quality standards.

Act as the quality lead throughout the product lifecycle
, partnering with cross‑functional teams to ensure products are designed, validated, and transferred to manufacturing in compliance with regulatory and quality standards.

We are specifically seeking candidates with experience in Gamma Radiation, E‑beam sterilization, and Design for Manufacturing (DFM).

• Bachelor’s degree in Engineering, Biological Sciences, or a related technical field
• Minimum 3+ years of experience in quality engineering within:
  Medical devices - Biopharmaceuticals - Manufacturing environments

Strong understanding of:

• Design for Manufacturing (DFM) principles
• Product scale‑up and manufacturing transfer

• Lead and support sterilization validation activities, with strong emphasis on:
  Gamma Radiation sterilization, Electron Beam (E‑beam) sterilization
• Ensure sterilization processes are validated, compliant, and effective
  , including activities such as:
  Dose audits, Bioburden assessments, Load configuration qualification
• Serve as the Quality lead on NPI projects
  , ensuring products are developed and transferred to manufacturing in compliance with quality and regulatory standards
• Support and drive Design for Manufacturing (DFM) initiatives to ensure products are scalable, efficient, and manufacturable at high quality
• Lead and support risk management activities (DFMEA / PFMEA) to identify and mitigate product and process risks
• Drive validation activities
  , including process validation and equipment qualification (IQ/OQ/PQ)
• Ensure manufacturing readiness by reviewing documentation, supporting pilot and engineering builds, and enabling smooth product transfer
• Work on impactful products in a regulated, high‑quality environment
• Collaborate with cross‑functional global teams
• Drive meaningful improvements in product quality and processes
• Grow your career in a dynamic and innovative organization

Work Authorization:

This role requires current authorization to work in the United States.
We are unable to provide visa sponsorship now or in the future