Quality System Specialist

This is a fully remote position, open to applicants in Singapore, +1 more country.

📋 Description

• Assist regional leaders in planning transitions for Quality Regional teams throughout Asia-Pacific nations.

• Conduct transition and site readiness activities across various locations in the Asia and Pacific regions.

• Aid in recognizing and implementing quality requirements necessary for establishing and enhancing global quality presence in APAC.

• Execute Quality Management System processes in accordance with relevant regulatory standards.

• Support QMS certification efforts, including ISO 13485 and ISO 9001, as applicable.

• Determine when Quality Agreements are necessary with third-party logistics providers, distributors, and other external partners.

• Identify essential Quality roles as mandated by country-specific regulations.

• Ascertain Post-Market Quality requirements and timelines for each country.

• Facilitate communication and manage dependencies with Regulatory Affairs, Supply Chain, Commercial, and Operations teams.

• Carry out other assigned tasks and responsibilities.

⛳️ Requirements

• Assist in transition planning for Quality Regional teams in the Asia-Pacific region and country-readiness initiatives.

• Possess experience or understanding of Quality Management System processes and relevant regulatory requirements.

• Familiarity with QMS certification standards, including ISO 13485 and ISO 9001.

• Ability to discern when Quality Agreements are necessary with 3PLs, distributors, and other external partners.

• Skill in identifying country-specific regulatory demands for mandatory Quality roles.

• Capability to identify Post-Market Quality requirements and timelines for each country.

• Proficient in coordinating with Regulatory Affairs, Supply Chain, Commercial, and Operations teams.

• Ability to operate across multiple locations within Asia and the Pacific region.

🏝️ Benefits

• Culture of face-to-face collaboration.

• Commitment to equal opportunity employment.