Quality Engineering - NPI

We’re partnering with a high-growth, global life sciences manufacturer at the forefront of
single-use bioprocessing technologies
.

They’re hiring an
NPI Quality Engineer
to sit at the intersection ofR&D, Manufacturing, and Quality
, ensuring new products are designed, validated, and successfully launched into GMP production.

• Act as Quality lead across
  New Product Introduction (NPI)programmes
• Drive
  design controls, risk management (DFMEA / PFMEA), and validation activities (IQ/OQ/PQ)
• Ensure
  manufacturing readiness
  for product launch (builds, documentation, transfer)
• Support
  sterilisation validation (EO, Gamma, E-beam)for single-use products
• Partner cross-functionally to deliver
  robust, scalable manufacturing processes
• Contribute to
  CAPA, change control, and continuous improvement

• Experience in
  biotech / pharma / medtech manufacturing quality
• Strong knowledge of
  ISO 13485 / 9001, GMP, and design controls
• Hands‑on experience with
  validation, risk management, and product transfer
• Exposure to
  cleanroom manufacturing and sterile products
• Ability to operate across
  cross‑functional product development teams

• Direct impact on
  bringing new products to market
• Work at the cutting edge of
  bioprocessing and single-use technologies
• Opportunity to influence
  product quality from design through to scale