JOB PURPOSE:

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.

DUTIES AND RESPONSIBILITIES:

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 externally.
• Recommend and justify product specifications and test methods appropriate to phase of development and product risk considerations.
• Ensure that products or services meet or exceed established quality standards and specifications.
• Stay current with industry standards and update internal standards and procedures as needed.

Testing and Inspection:

• Develop and implement testing and inspection protocols to identify and address deviations from quality standards.
• 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 testing.
• Ensure testing and release activities are executed in alignment with established schedules, quality requirements, and budget commitments.
• Ensure state of the art testing equipment are installed and plan for effective management and calibration of the equipment.

Defect Analysis:

• Collaborate in identification and analysis of defects and non-conformities to identify root causes.
• Implement corrective and preventive actions to address identified issues.
• 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.

QUALIFICATIONS & EXPERIENCE

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

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).
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in scientific form and deal with several abstract and concrete variables.
• Ability to comprehend and communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
• Strong systems-level technical thinking.
• Excellent communication and leadership capability.
• Hands-on research and design mindset.
• Strong organizational and prioritization skills.
• Comfortable operating in rapidly evolving environments.
• Ability to independently drive technical execution.
• High-accountability builder mentality.
• Hands-on, driven work ethic and entrepreneurial spirit

Computer Software / Programs

• Proficiency with Microsoft Office and technical presentation tools.
• Experience with eQMS and requirements/risk management platforms.
• Familiarity with, statistical tools, and modern research and design collaboration platform

• 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 externally.
• Recommend and justify product specifications and test methods appropriate to phase of development and product risk considerations.
• Ensure that products or services meet or exceed established quality standards and specifications.
• Stay current with industry standards and update internal standards and procedures as needed.
• Develop and implement testing and inspection protocols to identify and address deviations from quality standards.
• 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 testing.
• Ensure testing and release activities are executed in alignment with established schedules, quality requirements, and budget commitments.
• Ensure state of the art testing equipment are installed and plan for effective management and calibration of the equipment.
• Collaborate in identification and analysis of defects and non-conformities to identify root causes.
• Implement corrective and preventive actions to address identified issues.
• 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.

• Strong leadership skills and ability to collaborate effectively with team members
• 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).
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in scientific form and deal with several abstract and concrete variables.
• Ability to comprehend and communicate ideas and issues effectively to other team members and management.
• Ability to write and record data and information as required by procedures.
• Strong systems-level technical thinking.
• Excellent communication and leadership capability.
• Hands-on research and design mindset.
• Strong organizational and prioritization skills.
• Comfortable operating in rapidly evolving environments.
• Ability to independently drive technical execution.
• High-accountability builder mentality.
• Hands-on, driven work ethic and entrepreneurial spirit
• Proficiency with Microsoft Office and technical presentation tools.
• Experience with eQMS and requirements/risk management platforms.
• Familiarity with statistical tools, and modern research and design collaboration platform

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