Quality Engineering- Compliants
BioTalent Ltd, New York, NY, United States
We’re partnering with a high-growth, global life sciences manufacturer at the forefront of bioprocessing and single-use technologies.
They’re hiring a Quality Engineer to drive quality performance across complex, GMP manufacturing operations supporting leading biopharma customers.
The Role
Lead
quality investigations (complaints, non-conformances, sterility issues)
Own
root cause analysis + CAPA delivery
Partner cross-functionally across
Manufacturing, Engineering, R&D, and Supply Chain
Drive
continuous improvement (Lean / Six Sigma / SPC)
Act as key interface for
customer, supplier, and regulatory quality topics
Support
GMP, cleanroom, and validation-driven manufacturing processes
What They Need
Experience in
biotech / pharma / medtech manufacturing environments
Strong grounding in
QMS (CAPA, change control, deviations, validation)
Exposure to
GMP and ISO (9001 / 13485 / FDA)
Proven ability to
solve complex manufacturing quality issues
Comfortable operating in a
fast-paced, cross-functional environment
Why This Role
High-impact role supporting
cutting-edge biopharma manufacturing
Exposure to
complex, high-value products and global customers
Opportunity to drive
real operational and quality improvements at scale
#J-18808-Ljbffr
They’re hiring a Quality Engineer to drive quality performance across complex, GMP manufacturing operations supporting leading biopharma customers.
The Role
Lead
quality investigations (complaints, non-conformances, sterility issues)
Own
root cause analysis + CAPA delivery
Partner cross-functionally across
Manufacturing, Engineering, R&D, and Supply Chain
Drive
continuous improvement (Lean / Six Sigma / SPC)
Act as key interface for
customer, supplier, and regulatory quality topics
Support
GMP, cleanroom, and validation-driven manufacturing processes
What They Need
Experience in
biotech / pharma / medtech manufacturing environments
Strong grounding in
QMS (CAPA, change control, deviations, validation)
Exposure to
GMP and ISO (9001 / 13485 / FDA)
Proven ability to
solve complex manufacturing quality issues
Comfortable operating in a
fast-paced, cross-functional environment
Why This Role
High-impact role supporting
cutting-edge biopharma manufacturing
Exposure to
complex, high-value products and global customers
Opportunity to drive
real operational and quality improvements at scale
#J-18808-Ljbffr