Manager I Manufacturing Quality

Seeking a Manager I Manufacturing Quality with 6-12 years of experience in quality assurance, leadership, and quality systems. Bachelor's degree in Mechanical Engineering or Industrial Engineering required. Proficiency in English and computer literacy a must.

Requirements

• Bachelor's degree in Mechanical Engineering or Industrial Engineering, Specialty and or Master Degree
• 6 – 12 years of Quality Assurance experience in medical devices manufacturing or high volume of consumable products with medium automation environment
• Leadership position covering a large spectrum of QA work
• Familiar with 7 sub-systems of Quality System
• US Food and Drug Administration (FDA) regulations
• ISO9001 and or ISO13485 international standard
• Quality tools, e.g., Plan Do Check Act (PDCA), Statistical Process Control (SPC)
• Measurement System Analysis (MSA)
• Change Management
• Root Cause Analysis Methodologies
• Costumer Complaints Handling
• Quality Operations
• Process Validation, Software Validation
• Process Characterization
• Design of Experiments (DOE) and others
• Process Capability (Cp, Cpk, Ppk)
• Quality Assurance knowledge
• Internal Audit and/or Lead auditor certification
• Lean Manufacturing Basics
• Problem solving skills
• Interpersonal skills
• Critical Thinking
• Facilitating and communication skills
• Focus on Customer and Deliver Results
• Collaboration and Teamwork
• Communication with Impact
• Lead by Empowerment
• Strategic and Analytical Mindset
• Creativity and Continuous Improvement
• Adapt to Changes
• Take Initiatives to Decide and Act
• Commit to Regulations and Values
• Business and Professional Excellence
• Proficiency in English
• Computer literacy
• Use of statistical analysis software, e.g. minitab