Global Quality Specialist

COMPANY OVERVIEW        

We believe in Excellence, Integrity, Agility, Rigor and Fearlessness. To consistently deliver on our promise of “Better care. Better life”, these five core values form the bedrock of our identity, culture and success. They give us a common purpose and we all collectively understand them, work towards them and live by them every day.

2San is a global diagnostics company who is transforming the future of healthcare by delivering innovative home-testing, diagnostic solutions, that empower individuals to take control of their health and wellness, when and where they choose. We advocate for the movement that empowers people to own their own health and make informed decisions about it.

As a partner of choice, 2San’s client-base has spans government institutions worldwide, at central and region/state levels, the private healthcare sector, and some of the largest private sector corporations on the global stage. We have ambitious plans for our future and as a valued member of our team, we look to you to share in, and embody, our vision – to make our journey your journey. We’re invested in you and dedicated to fostering a vibrant culture that develops your skills, nurtures your potential, and stimulates your professional growth for a lasting career with us.

ROLE OVERVIEW      

The role of Global Quality Specialist will be to support the development of Quality Management System and provide ongoing quality assurance activities such as supplier & product onboarding, training, workflow design, documentation and KPI reporting. 

KEY ACCOUNTABILITIES/ RESPONSIBILITIES

• Supports the Quality strategy by suitable prioritization of activities, timely response to time-critical activities, and thorough documentation of essential evidence and key decisions within the Quality Management System 
• Facilitate the proper documentation of processes within the Quality Management System 
• Assist with supplier management activities to facilitate the NPD process 
• Assist with onboarding of new products onto the Quality Management System 
• Assist with monitoring and actioning of the quality inbox and flagging emails accordingly 
• Assist with upload of product artwork to eQMS to ensure compliance
• Liaise with the product team to gather all required supplier documents and product documents 
• Demonstrate the quality objectives in all activities and liaison with the wider business functions 
• Creation of non-conformance records on eQMS and coordination of actions within the team and cross-functional owners 
• Initiate non-conformance investigations and carry out root cause analysis activity  
• Creation of KPI reports for management review activity and weekly KPI metrics
• Creation of QTA agreements and co-ordinate execution of agreements 
• Support compliant handling process and ensure escalation when required  
  

PERSON SPECIFICATION/ REQUIREMENTS

• Life Science Degree preferred 
  
•  Familiarity with ISO 9001 / 13485, MDR and other global medical device legislation for quality management systems
• Previous experience of a regulated environment desirable  
• Willingness to learn and initiative to set own tasks from central team list required
  
• Experience of varied maturities of QMS and eQMS platforms advantageous
  
• Application of relevant quality management system activities: CAPA, Change Control, Risk Management, Documentation
  
• Practical experience of working with stakeholders across the business 

CIRCUMSTANCES AND COMPENSATION  

• Fluent in English (C2 or above)
• Must be eligible to work in US time zone
• Location: Remote, work from home 
• Compensation: 52,500 PHP per month
• Perks & Benefits: Work from home, Paid training and ongoing learning & development courses, Access to 2San’s EapAssist Employee Program, Centr Fitness App and Wellness Subscription, Birthday and Anniversary Reward Points, Birthday and Special leave, Monthly Game Prize, 13th Month Pay, Annual PHL get together event, Annual Job Review and Contract Renewal
• We believe in looking after the people who power our business. That’s why we give everyone who joins access to Perkbox. It’s part of our commitment to look after you beyond just the pay packet. A Perkbox account gives you 24/7 access to perks, benefits, discounts, wellbeing tools and loads more!

TECHNOLOGY SET UP 

In addition to the above, you must also have the appropriate technology system & software in place as below:

• Internet not lower than 50 MBPS
• Laptop or PC with at least Intel Core i3 processor and 4GB RAM (or equivalent)
• Noise cancellation headset & a webcam
• An additional monitor screen is preferable but is not mandatory for the position. 

The above are the primary experiences, skills and competencies that the job holder will be required to demonstrate and to cultivate over time.  We expect that individuals will join us with the essential foundations and have a passion to develop and grow their career journey with us.