Quality Assurance Specialist

The Quality Assurance Specialist is responsible for supporting the implementation and maintenance of the Quality Management System (QMS) in compliance with applicable international standards and regulatory requirements. This role develops, implements, and maintains procedures within the QMS, and ensures it is effectively executed, maintained, and understood by all employees. The position also requires the ability to investigate and resolve quality-related issues and calls for close cross-functional collaboration to uphold a strong quality and compliance culture.

• Conduct and support both Internal and External audits as required.
• Works to achieve objectives of the QMS for Cook with QA policies, procedures and direction.
• Recognized subject matter expert with limited oversight from manger.
• Provide guidance, coaching and training for others.
• Responsible for making moderate to significant improvements of processes and systems to enhance operational efficiencies in alignment with quality objectives; including the authoring of documentation (e.g. procedures, policies, instructions).
• Support Quality Management Review data collection and analysis.
• Conduct investigations and perform gap analysis based on business needs; specifically as it relates to nonconformances, deviations and CAPAs within their specified electronic systems.
• Support the execution of both process and document control.
• Support change management activities (which may include Quality Review Board Meetings and reviewing changes for impact to the established QMS).
• Communicate the effectiveness of the QMS and any need for improvement to all relevant stakeholders and management taking action to correct any identified deficiencies.
• Work collaboratively with stakeholders to ensure metrics are met or exceeded by facilitating/leading interdepartmental meetings as appropriate to resolve issues.
• Assist in creating standards, processes and procedures as it relates to the established QMS.
• Provide education and training cross-functional and cross-divisional to support processes related to product leadership.
• Support the execution of both process and document control.
• Perform trending of quality data, ensuring proper application of CAPA and feedback loops are effective.
• Coordinate quality-related training programs and promote a strong quality culture across departments.
• Support field actions, product recalls, and mock recall exercises in accordance with company procedures.
• Coordinate the generation, review, approval, translation, formatting, and publishing of Chinese Instructions for Use (IFU) and labeling materials.
• Participate in local or regional projects as assigned.
• Comply with the Cook Code of Conduct, Company Values, Competencies, and Company Compliance requirements.
• Perform other duties as assigned by the Manager, Quality Assurance.

Education and/or Work Experience Requirements:

• Bachelor’s degree or above in Medicine, Biology, Pharmacy, or related sciences.
• 3+ years of relevant experience, preferably within the medical device, pharmaceutical, healthcare, or other highly regulated industries.
• Knowledge and practical experience in medical device regulatory registration.
• Fluency in English and Mandarin (written and spoken ability).
• Proficient in Microsoft Office Applications including Excel, Work and PowerPoint.
• Familiarity with medical device regulations such as ISO 13485, QSR, GDP, TFDA is preferred.

Personal Attributes:

• Reliable, punctual and dependable.
• Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards.
• Analytical approach to problem solving with innovative thinking.
• Highly organized with a focus on attention to detail.
• Approach daily tasks with flexibility, initiative and enthusiasm.
• Ability to interact effectively with internal and external stakeholders at all levels and functions across the business.
• Ability to follow instructions and take directions.
• Ability to work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must have effective communication skills and ability to work in collaborative and independent work situations and environments.
• Ability to remain calm and receptive in fast-paced situations.
• Flexibility to attend calls and meetings outside of normal working hours is required.