Job Description

Post Nos: MHT- QAR-002
Job Title: Quality Assurance Officer
Basic salary: ₱ 37,828.00 - 48,420.00

Please note: Due to the high number of applications, review and pre-selection could take several weeks. Only applications from qualified candidates will be considered for further processing. Short-listed candidates will be notified for further screening and interview as necessary.

CLOSING DATE FOR APPLICATIONS:
Applications received after the Closing Date will no longer be considered.
Post Context:
Manila HealthTek Inc. (MTek Inc.) is a private Research & Development company with a robust diagnostic technology pipeline. It develops and manufactures portable diagnostic kits for the diagnosis of selected infectious diseases in the Philippines and in the region. The Quality Assurance Office is directly responsible to the Chief Executive Officer (CEO) for all Quality matters. The Director, Quality & Safety represents the CEO on all quality-related matters. Responsible for liaising with the National Quality Assurance Representative (NQAR) on all quality-related matters. Responsible for implementing and documenting the Company Quality Management System (QMS) in accordance with pre-defined international standards (ISO 13485, ISO 9000). Assures implementation of ISO standards as required by the Company. Defines authorities, interrelationships, and responsibilities of Company personnel to assure quality doctrine and objects are met. Promulgates quality policy, procedures, and instructions in line with international standards on quality (ISO). Ensures that all policies, procedures, and instructions are referenced within the QMS. Through development and implementation of the QMS assures products and services meet customer and applicable regulatory requirements. Addresses risks and opportunities associated with Company goals and objectives. Enhances customer satisfaction through effective application of the quality system, including processes for continual improvement and product conformity in compliance with applicable regulatory documentation. Provides guidance to the Companys’ employees on all aspects of the QMS to ensure customer satisfaction and continuous improvement. Establishes and ensures the application and execution of the QMS by appointing and training departmental Quality Assurance and Quality Control Officers. The Quality Assurance Officer (QAO) assists with the implementation and ISO accreditation and certification and provides expertise and support in all Quality related matters.

The successful candidate will possess the following:

Personal Attributes/Competencies:

• Must have very good knowledge and experience of Microsoft Office applications and Visio/Flowcharting software.
• Must possess above-average language skills in English and Filipino and excellent communication skills, both oral and written, combined with the ability to formulate procedural, policy, and other related documentation. Initiative, reliability, and being proactive are essential.
• The ability to optimize productivity, streamline functional processes and achieve a continuous improvement is essential.
• Must be adept in articulating and developing improvement initiatives spanning across all departmental functions.
• The ability to act as a catalyst for change and improvement initiatives in performance and quality is essential.

Experience:

• At least 2-year’s experience in any industry with a manufacturing set-up.
• Experience implementing ISO9001 or similar Management Standards.
• Knowledge in Quality Tools and Process Control.
• A minimum of at least 3-years of current related experience in quality inspection, auditing, and testing in the medical diagnostics-related industry.
• Experience in effective usage of data analysis tools and statistical analysis.
• Knowledge of relevant regulatory requirements.
• Experience with implementing corrective action programs.
• Knowledge of tools, concepts, and methodologies of Quality Assurance.

Education/Training:

• Any 4-year Business/Engineering/Medical Course, or a related subject.

The following is considered highly desirable:

Professional/Experience:

• At least 5-years’ experience in medical device facility (manufacturing/distribution).
• Experience implementing ISO13485.
• Has undergone any Quality Lead Auditor (IRCA) course and has served as Quality Management Representative (QMR) or Deputy QMR.
• Familiar with Six Sigma.

Education/Training:

• Graduate of Business/Medical or Industrial Engineering, or a related subject.
• Certificate/License as a Quality Lead Auditor and/or Six Sigma at Green Belt level.

Principal Duties:

• Provides guidance on Quality Standards (ISO9001, ISO13485) implementation.
• Provides Quality Audits scope, framework, and policies.
• Monitor’s corrections and corrective actions.
• Identifies training needs for employees and recommends training interventions to meet quality standards.
• Maintains and submits overall quality performance analysis reports.
• Manages risk by ensuring compliance with policy, quality, and operational standards.
• Provides in-house, basic, refresher, and other training as required.
• Undergoes in-house, basic, refresher, and other training as required.
• Performs other related duties as assigned, and as qualified.

Additional Duties:

• May be required to travel to other locations in fulfillment of work-related assignments.

About Manila HealthTek :

Over the last 5 years, our team has been silently working in the laboratory to find diagnostic solutions to diseases in which timely diagnosis could potentially save lives. We all shared in the vision that someday, we will not just sit on the side-lines while our foreign counterparts find solutions to our own health problems, but as Filipino scientists finding solutions to the health problems of our fellow Filipinos and beyond. Manila HealthTek, Inc. (MTek, Inc.) is the first of its kind in the Philippines. It is principally a private Research and Development company with a robust diagnostic technology pipeline. As a first ever university spin-off from the University of the Philippines, it will develop and manufacture portable diagnostic kits for the diagnosis of selected infectious diseases in the Philippines and in the region. MTek, Inc. recognizes the potential of the isothermal platform and other emerging biotechnologies to be utilized in designing novel and quality point-of-care diagnostic kits that are as rapid and accurate as the most advanced molecular diagnostic tools available in the market, yet affordable to a majority of low-to-middle income Filipino patients who are mostly the ones afflicted with infectious diseases. As such, MTek, Inc. hopes to help in reducing the burden of infectious diseases by providing timely diagnostic intervention through affordable, simple yet accurate technologies. Moreover, scale-up manufacturing and commercialization of an array of diagnostic kits in the product pipeline provides an excellent opportunity to contribute to the macroeconomic growth of the country. The company is founded and managed by highly-trained and multi-awarded Filipino scientists and experienced partner-entrepreneurs. We will likewise be the home of similar Filipino scientists who will be at the forefront of science and research in the region without having to leave the country.