Job Details

Roles & Responsibilities:

• 4-6 years Minimum bachelor's or master's degree in a health-care related field
• Strong knowledge of GMP (Good Manufacturing Practices) and ISO 13485 standards, along with regulatory affairs.
• Strong creative, analytical, and problem-solving skills.
• Proficient in interpreting data and compiling detailed reports.
• Expertise in Design Quality, Good Manufacturing Practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, and Manufacturing Processes.
• Expertise in statistical analysis and root cause analysis.
• Strong CAD skills (preferred: AutoCAD and SolidWorks).
• Experience in fixture design, FMEA creation, and report writing.
• Knowledge of Post Market Surveillance (PMS) and PLM tools (Windchill).
• bility to observe, understand, and optimize manufacturing processes.
• Excellent interpersonal, communication, organizational, and project management skills.
• Proficiency in Windows-based software (Word, Excel, PowerPoint, email, and web browsers).
• bility to work efficiently, meet deadlines, and communicate project status effectively.

• Investigate field return products and perform root cause analysis.
• Optimize manufacturing processes and work with stakeholders to reduce scrap.
• Identify and implement process improvement opportunities.
• Support design enhancement initiatives.
• Collaborate with cross-functional teams (engineering, manufacturing, marketing, and suppliers).
• Create Engineering Change Orders (ECOs) to update documentation in the PLM system (Windchill).
• dhere to company policies, procedures, and training requirements.