Quality Engineer in a Medical Device Facility

QA

Bar-Lev

Position 1033

Position Overview:

As a Quality Engineer in a medical device facility, primary responsibility is to ensure that all processes, systems, and products meet or exceed quality standards and regulatory requirements.

You will be involved in various stages of the product lifecycle. Your role is crucial in maintaining the safety, efficacy, and reliability of medical devices produced in the facility.

Key Responsibilities:

Quality Assurance Processes:

• Develop, implement, and maintain quality assurance procedures and processes in compliance with relevant industry regulations and standards (e.g., FDA, ISO 13485).
• Establish quality control measures, including inspection techniques, sampling procedures, and testing protocols.
• Conduct internal audits to identify areas for improvement and ensure adherence to quality standards and procedures.
• Participate in risk management activities, including the identification and mitigation of potential quality risks.
  
  

Supplier Management:

• Collaborate with the purchasing department to evaluate and select suppliers based on their quality management capabilities.
• Establish quality agreements with suppliers and conduct supplier audits to ensure compliance with quality standards.
• Monitor and evaluate supplier performance, addressing any quality issues promptly.
  
  

Manufacturing Support:

• Provide support to manufacturing teams in implementing and maintaining quality control measures on the production floor.
• Collaborate with manufacturing engineering to develop and optimize manufacturing processes to ensure product quality and efficiency.
• Investigate and address any quality issues or non-conformities identified during the manufacturing process.
  
  

Corrective and Preventive Actions (CAPA):

• Lead investigations into quality issues, customer complaints, and non-conformities to identify root causes.
• Develop and implement effective CAPAs to address identified issues, ensuring timely completion and verification of effectiveness.
• Monitor and track CAPAs to ensure appropriate follow-up and closure.
  
  

Post-Market Surveillance:

• Participate in post-market surveillance activities, including complaint handling, adverse event reporting, and product recalls.
• Analyze post-market data and trends to identify opportunities for product and process improvements.
• Collaborate with cross-functional teams to implement necessary actions based on post-market surveillance findings.
  
  

Training and Documentation:

• Develop and deliver training programs on quality assurance principles, regulatory requirements, and good manufacturing practices (GMP).
• Maintain comprehensive documentation of quality processes, procedures, and records, ensuring accuracy and traceability.
  
  
  

Qualifications and Requirements:

• Bachelor's degree in engineering, life sciences, or a related field. A master's degree is a plus.
• Proven experience (typically 2+ years) in quality engineering or a related role, preferably in the medical device industry.
• Strong knowledge of quality management systems, regulatory requirements (e.g., CE, FDA, ISO 13485), and relevant industry standards.
• Familiarity with design control principles and experience in participating in design reviews.
• Solid understanding of manufacturing processes, quality control methods, and statistical techniques.
• Experience in conducting root cause analysis, risk assessments, and implementing corrective and preventive actions (CAPAs).
• Excellent problem-solving skills and the ability to analyze complex situations and make sound decisions.
• Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
• Excellent communication skills, both written and verbal, with the ability to effectively communicate with cross-functional teams.