Quality System Engineer II

Summary

Balt is a rapidly growing pioneer in the medical devices field, focused on improving the lives of patients. The Quality System Engineer II will support the quality system for medical device manufacturing, coordinating audits, document control, and process improvements.

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

• 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
• ASQ certification a plus
• 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
• 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
• 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

Qualifications

Must Haves

• 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
• ASQ certification a plus
• 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
• 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

• 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