Quality Control Manager

• Master’s degree in biomedical field is
  
• 7+ years of experience in medical device quality control with demonstrated hands on laboratory
  
• Experience working within ISO 17025 and ISO 13485-aligned quality
  
• Experience supporting WHO or global device regulatory
  
• Background supporting medical device development and evaluation
  
• Familiarity with data integrity requirements and lifecycle management of analytical methods for medical
  

Preferred skills

• Strong leadership skills and ability to collaborate effectively with team members and Familiarity with medical device quality control concepts, test methods, equipment and applicable national and international standards relating to testing ISO 13485, WHO and other stringent regulatory authorities (SRAs).
  

These roles include but are not limited to:

Quality Control System Implementation:

• Establish and maintain a comprehensive quality control system that aligns with departmental objectives and industry standards and regulations including ISO 13485, WHO and other stringent regulatory authorities (SRAs).
  
• Implement standardized processes for inspection, testing, and evaluation of products or services.
  

Standards and Specifications:

• Design, implement, and maintain Quality Control processes and specifications, analytical methods, protocols, and reports, both internally and
  
• Recommend and justify product specifications and test methods appropriate to phase of development and product risk
  
• Ensure that products or services meet or exceed established quality standards and
  
• Stay current with industry standards and update internal standards and procedures as
  

Testing and Inspection:

• Develop and implement testing and inspection protocols to identify and address deviations from quality
  
• Review and approve development, release, and stability data for routine manufacturing, investigations, and deviations
  
• To evaluate and monitor any contract analysis done on behalf of MHS by serving as the primary QC technical liaison with external testing laboratories supporting device component
  
• Ensure testing and release activities are executed in alignment with established schedules, quality requirements, and budget
  
• Ensure state of the art testing equipment are installed and plan for effective management and calibration of the
  

Defect Analysis:

• Collaborate in identification and analysis of defects and non-conformities to identify root
  
• Implement corrective and preventive actions to address identified
  
• Ensures the nonconforming material identified from receiving, in-process, and finished device acceptance is identified, documented, and communicated to affected parties for timely and effective resolution
  

Process Monitoring:

• Implement real-time monitoring systems to track key quality metrics during production or service delivery.
  
• Utilize statistical process control methods to maintain process consistency and predictability of quality of the
  

Supplier Quality Management:

• Support qualification of alternate laboratories, material and service suppliers, and device component
  
• Collaborate with the procurement and supply chain teams to ensure that suppliers meet quality requirements.
  
• Support in assessments and audits of key suppliers and service providers
  
• Track, trend, and report compliance metrics and quality performance indicators; recommend and implement supplier performance metrics basing on tested
  

Training on Quality Control Procedures:

• Provide training to employees on quality control procedures and the importance of adhering to established standards.
  
• Foster a culture of quality awareness throughout the
  

Root Cause Analysis:

• Facilitate and lead root cause analysis investigations for significant quality
  
• Implement corrective actions to address root causes and prevent
  

Quality Metrics and Reporting:

• Establish key performance indicators (KPIs) to measure the effectiveness of quality control
  
• Generate regular reports on quality metrics and present findings to top management
  

Continuous Improvement:

• Promote a culture of continuous improvement by identifying opportunities to enhance quality control
  
• Encourage feedback from employees and stakeholders to drive
  

Customer Feedback Analysis:

• Analyze customer feedback and complaints related to product or service
  
• Use customer input to drive improvements in quality control
  

Regulatory Compliance:

• Ensure that quality control processes align with regulatory
  
• Prepare for and manage external audits related to quality
  

Validation:

• Ensure analytical methods are validated as per approved procedures
  
• Ensure the equipment used in the laboratory is qualified and calibrated prior to use