Senior Quality Engineer

Your challenge

• Set detailed guidelines on inspection and testing requirements
• Ensure products adhere to company and industry quality standards
• Develop inspection methods to analyze product quality
• Identify and lead CAPA and process improvement initiatives
• Develops, maintains and monitor measurement processes to ensure compliance to ISO and FDA regulations
• Collaborate with supplier to investigate root cause and corrective actions when raw material or component deficiencies are detected
• Monitor and evaluate supplier process for compliance to purchase order and engineering requirements
• Deploy variation management tools and techniques at select suppliers to mitigate risk
• Audit suppliers and establish supplier quality requirements
• Reporting on supplier trends for management review and notification of identified trends to management for management review
• Design and implements methods for process control, process improvement, testing, and inspection
• Establish and maintains process flow diagrams, workplace layouts, FMEAs and standardize work instructions
• Other duties as assigned

• Bachelor’s degree in engineering field or related field. Master’s degree in engineering is preferred.
• 3-7 years of experience in high volume regulated manufacturing industry in engineering field.
• Working experience of Six Sigma, lean and Quality Management Tools
• A broad knowledge of theory and principles of statistics and statistical process control
• Experience with Access Database, Excel and complaint handling software.
• In-depth knowledge of ISO
  13485, ISO
  14971, CFR part 820.
• Good understanding of medical device regulation, industry, and international standards.
• Strong computer skills in MS Office
• Ability to recognize and projects
• Ability to read and understand technical drawings and documents
• Working experience on CAD/Solid Works
• Ability to work independently and take initiative
• Excellent communication, analytical, trouble-shooting and interpersonal skills
• ASQ Lead Auditor or equivalent training in auditing
• A team player as well as the ability to work independently

• Must be able to work overtime as needed
• Must be able to sit, stand and walk for up to 8 hours
• Must be able to lift up to 70 lbs