Quality Systems Engineer II - Med Device CAPA & Audits

Balt USA; Irvine (CA); On-site; USD 90,000 - 100,000; Full time

Job summary

Balt USA is seeking a Quality System Engineer II to support its quality system, including coordinating NCMRs and CAPAs, audit support, and document control and training compliance. The role works with multiple functions and leadership to improve QS processes for neurovascular medical devices.

Requirements include a Bachelor’s in engineering/science, 3+ years in a related field, medical device or pharma experience, data analysis skills, and ASQ is a plus.

Qualifications

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

Responsibilities

• Knowledge of quality systems for medical device manufacturing and requirements for manufacturing, inspection and testing.
• Plans, documents (protocol and reporting) product/process validations.
• Participate in audit activities.
• Initiate and/or verifies corrective and preventative actions resulting from NCMRs, CAPAs, audit findings and customer complaints.
• May help with qualifications for manufacturing transfer activities, including new or changed materials and processes, equipment IQ/OQ/PQ/PPQ.
• Identify, evaluate, and supports software validation activities.
• Lead meetings for process improvement and problem solving.
• Communicate with process stakeholders to address quality concerns and resolves issues.
• Maintain and develop processes and procedures by writing standard work instructions for quality system enhancements supporting production and quality controls.
• Have a clear understanding of FDA’s QMSR, ISO 13485 requirements, EU medical device regulation, and a good understanding in the application of statistics to process analysis and improvement.

Skills

Attention to detail

Technical writing

Independent worker

Cross-functional teamwork

Communication skills

Risk management

Process validation

CAPA process

Documentation

Design controls

Statistical analysis

Education

Bachelor's degree in engineering or science

Tools

Microsoft Project

Word

Excel

PowerPoint

Windows

Visio

Job description

Balt USA is seeking a Quality System Engineer II to support its quality system, including coordinating NCMRs and CAPAs, audit support, and document control and training compliance. The role works with multiple functions and leadership to improve QS processes for neurovascular medical devices.

Requirements include a Bachelor’s in engineering/science, 3+ years in a related field, medical device or pharma experience, data analysis skills, and ASQ is a plus.