Principal Quality Engineer

Olympus Corporation is a global medical technology company committed to improving patient outcomes through innovative solutions. They are seeking a Principal Quality Engineer who will focus on product quality, ensuring patient safety and customer satisfaction while leveraging problem-solving expertise and leadership skills.

Responsibilities:

• Train, coach, and support CAPA Site Leads in the application of technical and analytical methods that accelerate CAPA closure and effectiveness; provide coaching for CAPA owners to drive the development of sound problem-solving and technical design review habits and techniques across Olympus
• Ability to support the use of quality problem-solving tools such as Root Cause Analysis, 5 Whys, Ishikawa, etc
• Deploy and oversee a Design Assurance Quality Engineer training and development syllabus supporting the development of a patient-focused Quality Mindset and technical rigor across the Design Quality Assurance function
• Leverages extensive technical experience to support high visibility new product development, sustaining engineering and CAPA efforts as assigned by Management
• Supports high-priority complaint investigations, signal detection, and product issue escalations
• Other Quality Assurance responsibilities as assigned by Management

Requirements:

• BS degree or equivalent in an engineering or life science discipline
• Minimum of 8 years' experience working in an FDA regulated environment
• Demonstrated ability to manage and complete multiple projects and objectives and lead cross-functional teams
• Proficient with DMAIC/ Lean Six Sigma /Black Belt tools to analyze, drive root cause, and solve difficult problems
• Proficient with statistics, sampling strategies, quality systems trending, and process capability
• Proficient with Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDAQSRs, ISO 13485, ISO 14971
• Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities
• Strong track record of leading and influencing without direct authority across functional groups, leadership levels and regions globally
• Excellent interpersonal, communication (written and oral), presentation and facilitation skills
• Demonstrated ability to coach and mentor others
• Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio)
• Demonstrates the highest ethical standards and actively promotes trust, respect and integrity in all dealings both inside and outside the Company
• Six Sigma Green Belt Certification required
• Ability to travel up to 20% of time domestically and internationally
• Minimum of 3 years' experience working in Medical Device or Pharma
• Six Sigma Black Belt is preferred