Quality Specialist

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 (https://www.smith-nephew.com/)

• 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.