Quality Engineer II / Sr Quality Engineer

The Quality Engineer II/Sr Quality Engineer will be responsible for applying/interpreting quality systems, developing/implementing standard operating procedures, and ensuring documentation compliance. The role will also provide guidance on quality system elements, process control, supplier qualification, and continuous improvement.

Requirements

• Independent writing and execution of process validation protocols
• Experience in a medical device or pharmaceutical manufacturing facility
• Moderate knowledge of FDA 21 CFR 820 and ISO 13485
• Clinical diagnostic experience a plus
• Ability to manage multiple tasks and drive execution of change management plans
• Ability to lead or manage process control, supplier quality, and continuous improvement projects
• Statistical technique/tools such as: Statistical sampling, SPC
• FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans, trending, and design control
• Initiates and/or supports CAPAs and may lead the investigation/corrective action process
• Supports implementation of corrective actions and improvements
• Responsible for initiating and coordinating SAP data/documentation in current products
• Drives for continuous improvement in all areas
• Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures

Benefits

• Paid time off
• Health insurance
• Retirement plan
• 401k matching
• Life insurance
• Disability insurance