Quality Control Manager job at Microhaem Scientifics and medical supplies

Background

The Quality Control (QC) Manager shall ensure that all MHS products and processes adhere to quality standards. Your responsibility extends across various departments and processes to maintain or exceed the established quality standards and uphold our commitment to manufacture safe and effective medical devices. This work includes release testing, stability programs, methods transfers, and validations at external laboratories and Contract Development Organizations (CDOs).

Overall, the Quality Control Manager is responsible for ensuring that the company`s quality control system is effective, efficient, and compliant with regulatory requirements, and that it meets or exceeds customer expectations. The QC Manager is responsible for overseeing all aspects of quality control, including policies, procedures, audits, and corrective actions, and working closely with other departments and teams to ensure that quality is embedded throughout the processes.

Responsibilities

• 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.
• 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
• 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
• 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
• 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
• 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
• Provide training to employees on quality control procedures and the importance of adhering to established standards.
• Foster a culture of quality awareness throughout the
• Facilitate and lead root cause analysis investigations for significant quality
• Implement corrective actions to address root causes and prevent
• Establish key performance indicators (KPIs) to measure the effectiveness of quality control
• Generate regular reports on quality metrics and present findings to top management
• Promote a culture of continuous improvement by identifying opportunities to enhance quality control
• Encourage feedback from employees and stakeholders to drive
• Analyze customer feedback and complaints related to product or service
• Use customer input to drive improvements in quality control
• Ensure that quality control processes align with regulatory
• Prepare for and manage external audits related to quality
• Ensure analytical methods are validated as per approved procedures
• Ensure the equipment used in the laboratory is qualified and calibrated prior to use

Qualifications & Experience

• 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
• 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).

• 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.
• 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
• 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
• 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
• 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
• 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
• Provide training to employees on quality control procedures and the importance of adhering to established standards.
• Foster a culture of quality awareness throughout the
• Facilitate and lead root cause analysis investigations for significant quality
• Implement corrective actions to address root causes and prevent
• Establish key performance indicators (KPIs) to measure the effectiveness of quality control
• Generate regular reports on quality metrics and present findings to top management
• Promote a culture of continuous improvement by identifying opportunities to enhance quality control
• Encourage feedback from employees and stakeholders to drive
• Analyze customer feedback and complaints related to product or service
• Use customer input to drive improvements in quality control
• Ensure that quality control processes align with regulatory
• Prepare for and manage external audits related to quality
• Ensure analytical methods are validated as per approved procedures
• Ensure the equipment used in the laboratory is qualified and calibrated prior to use

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

• Master’s degree in biomedical field
• 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