Quality Engineer - Operations

• Approve quality system documentation and engage in cross-functional development teams for the creation and launch of new products.
  
• Take part in and lead cross-functional improvement projects and CAPAs, and offers technical support to the QC department.
  
• Guide the introduction of new or enhanced products and facilitate the transfer of technology from development to commercialization, all with a keen focus on maintaining high-quality standards.
  
• Examine the outcomes of Risk Analyses and spearhead cross-functional initiatives to pinpoint suitable risk mitigation actions.
  
• Creates and sustains inspection plans utilizing suitable methodologies to guarantee that products adhere to specifications and are safe and effective for use.
  
• Recognize and execute opportunities for continuous improvement.
  
• Collaborate and coordinate activities with other departments, external vendors, and customers.
  
• Aid or take the lead in swiftly implementing Quality-related projects, including resolving non-conformances, investigating complaints, and implementing Corrective and Preventive Actions (CAPA), as well as Process Validations.
  

• Must have a minimum of 3 years experience in the medical device industry.
  
• Proficient understanding of medical device Design Control and Quality System requirements, including 21CFR820, ISO13485, and ISO14971.
  
• Possesses strong technical skills with a proven ability to offer solutions to various technical problems of moderate scope and complexity.
  
• Demonstrated experience and comprehension in the use of statistical tools.
  
• Capable of independently managing projects and leading cross-functional teams.
  
• Strong proficiency in both written and verbal communication, coupled with the ability to multitask in a fast-paced environment.
  
• Experience in supplier auditing.