Sr. QA Specialist – RSC

As the CVI owner, the Sr. QA Specialist – RSC guarantees that the CooperVision Regional Service Center adheres to both global and regional quality management requirements. This encompasses overseeing the quality management system (QMS) to ensure compliance with Medical Device Regulations (MDR), the Medical Device Single Audit Program (MDSAP), Good Distribution Practices (GDP's) and packaging standards.

Quality Assurance Regional Service Center Operations Management

• Partner with Global Regulatory Affairs team in setting up the Regional Service Centre to align with Global Regulatory Affairs frameworks.
• Conduct gap analyses between Regional Service Centre supplier current QA processes, ISO 13485, MDSAP, MDR, GDP requirements and Global QA system, ensuring full compliance.
• Oversees the development of Suppliers Standard Operating Procedures (SOPs), processes, supporting documents and training materials for quality assurance, global packaging, supply chain, and distribution activities.
• Provide technical expertise in quality management systems, risk assessment, and regulatory compliance to establish a strong foundation for Regional Service Centre operations. 
• Manages and conducts internal audits in any of the Regional Service Centre as required. This includes audit scheduling, planning, execution, and reporting.
• Monitor process audits to verify conformance with standard operating procedures.  This may include revising and / or creating SOP's as needed with relevant stakeholders.
• Maintaining the QA operation as CVI owner for Regional Service Centre once set up. Utilize the electronic Quality Management System (eQMS) to process and / or monitor changes and obtain approvals.
• Monitors product quality related packaging and distribution (Customer Complaints, Quality Feedback, Lot Blocks, Service Non-conformances etc.) and works with appropriate support department / sites to resolve problem(s). Performs archiving (as necessary) on quality related for record retention as applicable.
• Ensures quality standards are met for all products being packaged and distributed from the supplier and that all packaging and labeling materials meet CooperVision / Regional and International quality system requirements.
• Evaluates supplier distribution center and packaging performance capability and develops criteria to monitor and improve existing processes, as measured by appropriate quality KPIs. 
• Assists in product recalls and other regulatory submissions and responses as needed. 
• Regularly assessing supplier performance with Supplier audits

Contribution as Key Lead Quality Management member

• Develop and implement best practices to drive efficiency and compliance across the region.
• Develop strategies and plan to standardize and harmonize quality assurance processes across APAC to align with global requirements.
• Acts as the QA representative Subject Matter Expert and participates with cross functional teams on significant Regional Packaging and Distribution projects.
• Maintains open communication channel by regularly updating he relevant stakeholders on the progress of ongoing quality initiatives, ensuring transparency and fostering collaborative decision-making.

Contribution as Quality Management Partner in APAC Regional

• Collaborate with local Regulatory Affairs to ensure seamless adoption of harmonized processes as well as comply with country-specific regulations in APAC.
• Applies knowledge of Good Distribution Practices (GMP) regulations and industry standards as well as ISO general guidelines.
• Lead the harmonization processes projects within the region to drive efficiency and compliance as needed.

Others

Any other projects/tasks assigned.

Commercial travel: Approximately 30-40% per year

Knowledge, Skills and Abilities:

• Knowledge of medical device ISO13485, Medical Device Single Audit Program (MDSAP), Good Distribution Practices (GDP), MDR Distribution quality standard and regulations in APAC region. Related regulatory knowledge specifically in China, Korea, Taiwan and Singapore will be preferred.
• Strong knowledge of validation and stability will be preferred.
• Ability to read and understand technical material.
• Excellent attention to detail and organization skills.
• Excellent written and verbal communication skills.
• Computer literate, with intermediate skill in the use of Word, Excel, PowerPoint and Outlook, and some knowledge of relational database systems, e.g. eQuality  Management system (eQMS)
• Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with general supervision.
• Flexible and able to self-manage multiple priorities.
• Able to work effectively in multinational/multicultural environments.
• Exhibit professional behavior and image with internal and external parties.

Work Environment:

• Office environment.
• Prolonged use of a computer.
• Light lifting and bending.

Experience:

• At least 5 years of relevant professional experience in the medical device or pharmaceutical industry, with multi-site operations overseeing, preferably in high volume manufacturing/packaging and distribution operations
• Proficiency in developing, implementing, and maintaining eQMS, in compliance with medical device regulations.
• Preferably with experience in multiple countries, languages and cultures in the global company.
• Experience in planning, conducting, and reporting both internal and external audits. 

Education:

• Bachelor's degree in a scientific or technical discipline.