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Urgent! Quality Specialist Job Opening In Bangkok – Now Hiring Smith+Nephew

Quality Specialist

Quality Specialist



Job description

Quality Specialist based in Thailand

Life Unlimited. 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.

What will you be doing?

  • 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.

  • What will you need to be successful?

    Success in the role will require a combination of technical knowledge, soft skills, and a deep understanding of both the business and service-providing sides of an organization.

    Successful candidates would need the following:

  • 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.

  • You.

    Unlimited.

    We believe in creating the greatest good for society.

    Our strongest investments are in our people and the patients we serve.

  • Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website ()

  • Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.

  • Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!

  • Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.

  • Flexibility : Hybrid Working Model (For most professional roles).

  • Training: Hands-On, Team-Customised, Mentorship.


  • Required Skill Profession

    Other General



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