Senior Quality Engineer

Role Overview

• Oversee projects, maintain processes and address quality issues by analyzing outcomes and collaborating with teams
• Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes
• Create processes to better evaluate, track and trend audit outputs and identify risks/issues
• Independently performs supplier audits and corporate facility audits
• Manage multiple project tasks and effectively coordinate handling of customer feedback and complaints
• Lead assessment and closure of customer complaints, ensuring adherence to established procedures and documentation
• Lead the evaluation and resolution of customer complaints
• Coordinate communication between internal teams and customers
• Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication
• Reviews, revises, and creates operating procedures to ensure compliance
• Establish monthly KPI’s and metrics to Quality Leadership
• Drive continuous quality improvement projects across the enterprise for increased compliance and efficient use of company resources
• Review and approve laboratory procedures, work instructions, protocols, reports, etc.
• Liaise and collaborate with departments to initiate, investigate, review and approve OOS investigations and reports
• Conduct root cause analysis and issue appropriate corrective action
• Plan, host and co-ordinate Customer, ISO, Corporate QA, and Regulatory audits/inspections
• Coordinate responses to customer audit observations, customer complaints and request for information/documentation

Requirements

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred
• Minimum 5 years Experience in regulated Quality Assurance / Document/Configuration Control required
• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management preferred
• Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred
• Experience Leading Internal / External Audits, MasterControl, SAP and Share Point preferred
• Experience with customer interface and meeting customer expectations preferred
• Excellent written and verbal communication skills
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.
• Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485
• Familiarity with root cause analysis tools
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members
• Maintain high attention to detail, accuracy, and overall quality of work

Benefits

• Supported by benefit programs
• Empower the physical, mental, emotional and financial health of team members and their families