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Quality Specialist

Smith+Nephew (Thailand)
Smith+Nephew (Thailand) (Bangkok, Bangkok City, Thailand)
Bangkok, Thailand 🇹🇭
Smith+Nephew (Thailand)
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude, we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.

About this position

Quality Specialist based in Thailand. At Smith+Nephew, we design and manufacture technology that takes the limits off living. As Member of Quality Assurance team for Smith+Nephew-Thailand, this position shall be responsible for implementation of QMS as per ISO 13485:2016 & GDPMD, Complaint Handling, Coordinate Quality Holds & Recalls, provide Awareness & Training within the team, Handling of Non-conformances, corrective, preventive actions and Conducting Internal & Supplier Audits.

Responsibilities

• Support all QA activities for Commercial organization.
• Ensure compliance to ISO 13485:2016 & GDPMD requirements.
• Work with cross functional team to ensure compliance and bring improvements in the complete processes within the Sales, Marketing and Distribution channel.
• Conduct Internal audits.
• Support external audits by certifying agencies.
• Conduct product and process quality checks following established work instructions and sampling plans and ensure that all products and processes meet the standards, Customer, Quality and regulatory requirements.
• Maintain QMS documentation to current standards & needs.
• Handle Customer complaints.
• Proactively monitor sources of trends, complaints, failures, deviations, and changes to find opportunities for system, process, and product improvements.
• Ensure effective closure of Non-conformances, corrective and preventive actions.
• Build awareness on quality system requirements within the organization.
• Conduct Supplier Audits.
• Coordinate Quality Holds and Recalls.
• Work with Warehouse & Distribution partners to ensure compliance to S&N and ISO 13485/GDPMD requirements in respective areas.

Requirements

• Bachelor’s Degree in Biotech/Engineering/Pharma.
• 3 years of proven experience in quality assurance. Preferably in healthcare industry.
• Experience in Implementing QMS as per ISO 13485-2016 / ISO 9001:2015/GDPMD requirements.
• Experience in conducting audits.
• Internal Audit training certification for ISO 9001:2015 or ISO 13485:2016 or GDPMD requirements.