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.

Stay connected and receive alerts for jobs like this by joining our talent community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  

Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our new website and learn more about our mission, our team, and the opportunities we offer.