Site Quality Lead/Site Engineer - QA

About This Role

Lead the implementation of quality assurance practices, process control, change control, and Corrective and Preventive Action activities within the Operations Work Stream. This role ensures regulatory compliance and continuous improvement in value stream performance.

Responsibilities

• Provide Quality input to investigations, deviations, change controls, SOP's, and in-process controls for assigned Value Stream(s)
• Enable collaborative relationships between Operations and Quality to improve customer satisfaction
• Troubleshoot process issues and lead inter-department teams in their resolution
• Provide quality input and capability analysis to new product introduction teams
• Work with Operations, R&D, Purchasing, and Engineering to improve quality and reduce material scrap/costs
• Champion continuous improvement and transition to a Lean Manufacturing Environment
• Drive quality management focus on productivity improvements across the business unit
• Partner with Operations leadership to establish controls and inspection points to prevent nonconforming materials
• Drive customer complaints to resolution and serve as Quality Representative for corrective/preventive actions
• Lead PPI activities including Kaizen events and support process improvement activities
• Act as designated Management Representative for the Oakwood Village site, interacting with regulatory agencies
• Analyze trends, investigate trends with manufacturing, conduct root cause analysis, and lead corrective actions

Requirements

• Bachelor's Degree in a science, engineering or related field
• 4+ years of experience in a regulated environment (medical device, biotechnology, or clinical)
• Strong working knowledge of quality related tools (structured problem solving, FMEA, SPC, DOE, Six Sigma)
• Demonstrated working knowledge of quality and scientific principles
• Self-starter with ability to prioritize multiple tasks
• Strong working knowledge of various computer software for data analysis (Power Bi, Mini-tab)

Qualifications

• Bachelor's Degree in a science, engineering or related field
• 4+ years of experience in a regulated environment such as medical device, biotechnology, or clinical

Nice to Have

• Medical device, GMP, EU Regulation or ISO 13485 background
• Experience supporting medical device software and servicing
• ASQ certification
• Experience with lean manufacturing practices
• Green Belt or Black Belt certification

Skills

* Required skills

Benefits