Quality Engineer II

BALT Group • Irvine, CA

1d • Hybrid

About The Position

The Quality System Quality Engineer II will be responsible for supporting Balt USA’s quality system including, but not limited to, coordination of NCMRs and CAPAs, supporting audit execution, and supporting document control and training compliance. This Quality Engineer will be expected to work directly with different functions while receiving support and guidance from other engineering staff and the QS Supervisor to complete tasks. This position will have the responsibility to support and continuously improve current QS processes through technical and process innovation for the manufacture of neurovascular medical devices.

Requirements

• Bachelor’s degree required, preferably in an engineering or science discipline.
• 3+ years as an Engineer in a related field.
• Medical device or pharmaceutical experience.
• Data analysis skill set.
• Keen attention to detail when reviewing documentation and processes.
• Solid technical writing ability.
• Be able to work independently and cross functionally as part of a team.
• Comfortable communicating with a wide range of people from production, regulatory, management, suppliers, and other functions.
• General understanding of risk management, including design, use, and process FMEAs as well as a basic understanding of severity, occurrence, and risk mitigation and their impact on product and process controls.
• General understanding of process validation (OQ/PQ) and ability to develop test protocols/report to meet FDA and ISO requirements for class II and class III devices.
• Understanding of CAPA process and root cause analysis tools and how to use them.
• Ability to develop manufacturing documentation (e.g., manufacturing procedures, engineering drawings, BOM, work orders).
• General familiarity with design control requirements and V&V testing for new product designs.
• Effectiveness with lab equipment, assembly tools, and measurement devices.
• Basic understanding of statistical analysis techniques for identifying process capability and equivalence testing.
• Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required.

Nice To Haves

• ASQ certification a plus.
• Class II and III implantable medical device experience with focus on neurovascular devices.
• Strong communication skills working with multiple departments.
• A demonstrated ability to plan and run projects.

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.

Benefits

• Pride is a strong part of our identity.
• We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
• Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
• No matter the country, we take care of you.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level