Product Quality Assurance Analyst

The position of Product Quality Assurance Analyst is within our Cardiometabolic and Informatics Business Unit located in Manila, Philippines. This role will have frontline communications with established intake sites. Key attributes of this position include the ability to quickly and accurately ascertain all available information associated with complaints. Additionally, individuals in this position will be required to conduct analysis and follow up activities associated with these complaints. Finally, individuals in this position need to be able to work independently and in team environments in order to ensure complaints are analyzed and closed in accordance with established procedures.

Responsibilities and Duties

• Carries out duties in compliance with established business policies and procedures.

• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.

• Main responsibility is review, evaluate, investigate and close complaints, incl. escalate potential reportable events for evaluation of reportability

• Respond to inquiries regarding CMI BU products from customers and employees in other parts of the company

• Attend meetings with the intake sites departments, incl. perform active product follow-up with them

• Perform customer data analysis to identify product and market related trends as part of requested complaint searches, e.g. as part of CAPA investigations

• Prepare procedures that ensure good work processes in the department and that systems and documentation meet the requirements of GMP, ISO13485, and other relevant standards and regulatory requirements

• Perform product specific troubleshooting training as needed

• Responsibility for specific tasks will be reflected in the employee’s training plan

• Perform other duties and projects as assigned.

Authority

• The framework for the position is given by the regulatory requirements applicable to the IVD industry as defined in Quality Manual, Procedural Works, and plans established by the Quality Leadership Team in CMI BU

• The job holder prioritizes his / her daily work independently within given time limits and deadlines. If necessary, clarify priorities with the next in line manager, or project manager if the tasks are project-related

• The position holder has decision-making authority for the responsibilities given in paragraph 1 and approved project plans

Minimum Qualifications / Education / Experience

• Bachelor’s degree in natural sciences or equivalent technical discipline, and 2-5 years of relevant experience, or

• Master’s degree in natural sciences or equivalent technical discipline, and 1-3 years of relevant experience

• Lack of appropriate education level can be replaced / supplemented by 5 years’ internal experience in related fields

Preferred Qualifications

• Experience in complaint administration

• Experience from work with quality assurance, production and/or quality control according to GMP / ISO 13485 requirements

• Knowledge of diagnostics products’ technology, applications and expected performance

Personal Characteristics

• Excellent communication skills in English; in writing, reading and speaking

• Good ability to take initiative and work independently

• Good ability to analyze, and understand the customers’ needs

• Good documentation skills

• Precise and systematic