Senior Quality Engineer – Medical Devices & Regulatory Compliance

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

Job summary

Balda-C-Brewer in Ontario, CA, is seeking a Principal Quality Engineer to lead quality systems for Drug Delivery, IVD and Medtech projects. You will drive validation, QA processes, and supplier quality activities across multi-partner programs, ensuring compliance with ISO 13485 and FDA QSR.

You will mentor cross-functional teams, oversee CAPA, risk management, and process controls, and collaborate with external CDMOs to achieve robust design transfer, validation, and regulatory readiness.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or Industrial Engineering.
• Minimum of 8 years of quality engineering experience in the medical device industry.
• Experience managing suppliers of custom, precision-molded components.
• CQE, CQA or Six Sigma Belt preferred.
• Proficiency in Minitab for statistical analysis.
• Strong understanding of FDA QSR and ISO 13485 requirements.

Responsibilities

• Lead quality programs for Drug Delivery, IVD and Medtech projects across development to commercialization.
• Oversee design transfer, validation (IQ/OQ/PQ), and supplier quality activities with external partners.
• Manage CAPA, risk management, and process controls; drive continuous improvement.
• Collaborate with CDMOs and contract manufacturers to ensure compliance and timely delivery.

Skills

Quality engineering

Supplier management

Cross-functional leadership

Regulatory compliance

Validation strategy

Education

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

Tools

Minitab

Job description

Balda-C-Brewer in Ontario, CA, is seeking a Principal Quality Engineer to lead quality systems for Drug Delivery, IVD and Medtech projects. You will drive validation, QA processes, and supplier quality activities across multi-partner programs, ensuring compliance with ISO 13485 and FDA QSR.

You will mentor cross-functional teams, oversee CAPA, risk management, and process controls, and collaborate with external CDMOs to achieve robust design transfer, validation, and regulatory readiness.