• Responsible for complaint handling, reliability improvement, quality management, quality systems, continuous improvement, quality systems engineering, project management and regulatory compliance.
• Knows and applies the fundamental concepts, practices and procedures of the quality specialization.
  

Essential Duties & Responsibilities

• Complaint Handling
  
• Deliver Exceptional Customer Service to Complaint Originator
  
• Resolve Potential MDR Investigations < 25 Days
  
• Close Complaint Investigations < 60 Days
  
• Champion Root Cause Problem Solving
  
• Perform Risk Analysis and Reduction
  
• Author Quality / Regulatory Technical Reports (QRTRâ??s)
  
• Lead Customer Contact ?? Phone calls, letters, visits
  
• Draft monthly bulletins to Field Service Reps on the status of quality and improvements made
  

Reliability Improvement

• Trend service reports to identify top product issues and drive resolution
  
• Quality Management/ Quality Systems / Continuous Improvement
  
• Support Operations ? Ongoing support of critical quality issues as needed (ex: ship hold)
  
• Lead Quality Planning ?? Create and drive Quality Plan for Business Unit with COE Quality Leader
  
• Business Unit Highlights ?? Monthly data analysis and trending to support Quality Plan (ex: prep data)
  
• Statistical Support ? Lead Sample size selection, SPC, DOE, etc.
  
• Support SQE??s (as needed)
  
• Material Review Board (MRB)
  
• Fabrication Tooling Certification, Gage Plans, Gage R&R, Validation Support
  
• Vendor Management ?? Identify vendor quality issues and drive improvements
  
• Cost Reduction Team Support ?? Support initiatives as needed
  
• Special Projects ?? As needed by Business Unit and Department
  
• Support ECO & CAPA processes to ensure thorough and robust outcomes and enforce quality compliance (ex: Gage plans, FA, etc)
  
• Lead Quality centric problem solving 8Dâ??s and CAPA??s
  
• Quality Systems Engineering & Project Management
  
• Identify opportunities for enhancement of existing quality and regulatory systems/tools in support of our departmental and divisional visions.
  
• Provide quality support as a consultant to our organization to build understanding of quality concepts and drive our quality culture.
  
• Support AQE??s (as needed):
  
• Provide engineering specification and product design support to R&D teams through robust design practices (GD&T, etc)
  
• Participate in drawing development
  
• Develop control plans and inspection procedures
  
• Support GR&R with Metrology Specialist & AQT
  
• Participate in new product development process acting as a feedback loop from the field
  
• Regulatory Compliance
  
• Conduct Monthly Spider Web Audits and Quarterly Team Audits as required
  
• Participate in internal compliance audits ?? FDA, ISO, and Internal Audits
  
• Support external audits ?? Vendor and Sister Divisions
  
• Monitor compliance to Medical Quality Procedures and FDA Quality System Regulations (QSR??s) and update as necessary
  
• Regulatory Training ?? Conduct and support training on QSRâ??s, ISO, and RA Topics
  
• Monitor the ECO & CAPA processes meet all compliance requirements (ex: Write it Right!)
  

Minimum Qualifications

Education

• Bachelors Degree in Engineering or related field
  
• CPA of 3.0 or higher, strongly preferred
  

Qualifications & Experience

• Achieved a limited (learning) level of industry knowledge
  
• Competent with Microsoft Office (Outlook, Excel, Word, etc.)
  
• Must possess excellent oral and written communication skills
  
• Ability to solve problems in a high stress situation
  
• Possess attention to detail
  
• Eagerness to assist internal and external customers
  
• Manage projects in a timely manner
  
• Ability to conduct and document technical investigation
  
• Experience with GD&T and Statistical Analysis Capability, highly desirable
  
• Physical Requirements
  
• May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate
  
• May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities
  
• Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability
  
• Requires use of safety glasses in designated areas
  
• Closed-toe shoes must be worn on the production floor; safety shoes re recommended