Senior Quality Engineer for MedTech & Drug Delivery

Balda-C-Brewer; Ontario (CA); On-site; USD 100,000 - 145,000; Full time

Job summary

Balda-C-Brewer seeks a Principal Quality Engineer to lead quality activities for drug delivery, IVD and Medtech programs. You will guide design transfer, validation, and supplier quality across multiple partners, ensuring regulatory alignment and robust risk management.

The role emphasizes leadership in CAPA,LEAN/Six Sigma initiatives, and handling complex assemblies from design through commercialization.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, or Industrial Engineering.
• 8+ years of quality engineering experience in medical devices or combination products.
• CQE/CQA or Six Sigma Black/Green Belt preferred.
• Experience with external design, development and manufacturing partners.
• Proficiency in Minitab and statistical techniques for validation and QC.

Responsibilities

• Lead technical quality activities for Drug Delivery, IVD and Medtech platforms from concept to commercialization.
• Oversee design transfer, validation strategies, and supplier quality controls.
• Drive process validation (IQ/OQ/PQ) for molded and assembled components.
• Develop and maintain pFMEAs, control plans, acceptance criteria, and inspection docs.
• Lead CAPA investigations and ensure FDA 21 CFR Part 820 and ISO 13485 compliance.

Skills

Regulatory compliance

Process validation IQ/OQ/PQ

Risk management (pFMEA)

Supplier quality management

CAPA investigations

Education

Bachelor's in Mechanical/Biomedical/Industrial Eng

CQE/CQA or Six Sigma Belt

Tools

Minitab

DOE

Gage R&R

Job description

Balda-C-Brewer seeks a Principal Quality Engineer to lead quality activities for drug delivery, IVD and Medtech programs. You will guide design transfer, validation, and supplier quality across multiple partners, ensuring regulatory alignment and robust risk management.

The role emphasizes leadership in CAPA,LEAN/Six Sigma initiatives, and handling complex assemblies from design through commercialization.