Lead Quality Engineer - Medtech & IVD Platforms

Balda-C-Brewer; New York (NY); On-site; USD 120,000 - 150,000; Full time

Job summary

Balda-C-Brewer seeks a Principal Quality Engineer to lead quality activities for Drug Delivery, IVD and Medtech platforms, driving quality systems and process controls across complex programs with multiple components and external partners.

The role requires deep regulatory expertise (ISO 13485, FDA QSR) and a track record in validation strategy, supplier quality, risk management, and cross-functional leadership to ensure robust product development and successful commercialization.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or Industrial Engineering (preferred).
• Minimum 8 years of quality engineering experience in medical device or combination product industry preferred.

Responsibilities

• Lead quality engineering activities across drug delivery, IVD and Medtech projects.
• Drive development and validation strategies (IQ/OQ/PQ) for molded and assembled components.
• Oversee supplier quality, audits, and incoming inspection programs.
• Interface with suppliers and CDMOs to ensure quality agreements and part qualification.
• Lead CAPA investigations and ensure FDA 21 CFR Part 820 and ISO 13485 compliance.
• Contribute to continuous improvement via Lean/Six Sigma tools and design controls.

Education

Bachelor’s degree in Mechanical, Biomedical, or Industrial Engineering

Tools

Minitab

Statistical techniques

Job description

Balda-C-Brewer seeks a Principal Quality Engineer to lead quality activities for Drug Delivery, IVD and Medtech platforms, driving quality systems and process controls across complex programs with multiple components and external partners.

The role requires deep regulatory expertise (ISO 13485, FDA QSR) and a track record in validation strategy, supplier quality, risk management, and cross-functional leadership to ensure robust product development and successful commercialization.