The Quality Systems Engineer is responsible for maintaining and supporting processes that continually ensure medical devices are designed, developed and manufactured in accordance with the requirements of Invacare, globally.

The primary purpose of this newly created role in our Thailand hub, is create, plan and implement a new quality management system, to ensure we receive full accreditation under ISO:13485, by September 2021.

You will have the Australian and NZ QMS' to refer to, but your main deliverable and key responsibility will be to ensure that we have an Asia Pacific Quality Management System, that meets all requirements from and internal and external audit perspective.  Are you ready?

Key Responsibilities:

• Designing our new quality management system from scratch – including building a quality manual, writing procedures, work instructions, and all forms required to sustain a business like Invacare's.
• Work with the rest of the Invacare Thailand team to conduct the implementation of QMS
• Co-ordinate with accreditation party to ensure the business will go through the accreditation audit processes smoothly
• During day-to-day business, work with the rest of the APAC team to maintain quality system policies and procedures as required and seek continues improvement opportunities
• Collaborate with departments to resolve quality issues
• Co-operate and conduct quality audits, both internal and external
• Act as a leader and ambassador for corrective and preventative action activities
• Support data analysis of quality system data

Key Requirements:

• A tertiary qualification in Engineering or similar as it relates to this role
• Extensive experience working with ISO:9001, a knowledge and experience with ISO:13485 and ideally knowledge and experience working with ISO:16949.
• Lead auditor certification (ideal not essential)
• At least 5 years of experience in a similar role, ideally from the Medical Device or Automotive sectors
• Experience building and implementing a new QMS for a multinational organisation
• Experience working within in a highly regulated industry such as Medical Devices preferred
• Excellent command of the English language, both written and verbal
• Advanced Microsoft Office proficiency (Excel, Word, PowerPoint, Teams)
• The ability to collaborate across borders with management and colleagues, to ensure continued certification is achieved.
• Excellent attention to detail, timeliness and accuracy are critical to your success

About Invacare

    Invacare helps you to grow, both personally and professionally. Invacare is somewhere you can make a real difference to lives of our customers around the world. We don't want you to work for us. We want you to join us on our journey, welcome to the Invacare family!

    Invacare has great plans for 2021 and a wide variety of new exciting products to launch. Join our journey. Apply now

Invacare helps you to grow, both personally and professionally. Invacare is somewhere you can make a real difference to lives of our customers around the world. We don’t want you to work for us. We want you to join us on our journey, welcome to the Invacare family!

Invacare has great plans for 2021 and a wide variety of new exciting products to launch. Join our journey.