Quality Engineer II, Medical Devices — QA & CAPA

BALT Group; California; On-site; USD 90,000 - 100,000; Full time

Job summary

Balt USA is seeking a Quality Engineer II to support our quality system for neurovascular medical devices in California. You will coordinate NCMRs and CAPAs, assist audits, and manage document control and training compliance while collaborating with engineering and manufacturing teams.

Ideal candidates have a bachelor’s degree in engineering or science, 3+ years in medical devices, and experience with FDA/ISO quality systems.

Qualifications

• Bachelor’s degree in engineering or science required.
• 3+ years as an engineer in a related field.
• Medical device or pharmaceutical experience.
• Data analysis skill set.
• ASQ certification a plus.

Responsibilities

• Quality systems knowledge for medical device manufacturing.
• Plan and document product/process validations.
• Participate in audit activities.
• Initiate and verify CAPAs and NCMRs, audit findings and customer complaints.
• Assist with manufacturing transfer qualifications (materials/processes, IQ/OQ/PQ/PPQ).
• Identify, evaluate and support software validation activities.
• Lead process-improvement meetings and problem solving.
• Develop and write standard work instructions for quality controls.
• Understand FDA QMSR, ISO 13485, EU medical device regulation and apply statistics to process analysis.

Skills

Quality Systems

Data Analysis

Statistics

Technical Writing

Cross-Functional

Process Validation

CAPA & NCMR

Documentation

MS Office

Education

Bachelor's degree

Tools

MS Office

Job description

Balt USA is seeking a Quality Engineer II to support our quality system for neurovascular medical devices in California. You will coordinate NCMRs and CAPAs, assist audits, and manage document control and training compliance while collaborating with engineering and manufacturing teams.

Ideal candidates have a bachelor’s degree in engineering or science, 3+ years in medical devices, and experience with FDA/ISO quality systems.