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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management System processes and regulatory compliance, with a strong focus on ISO 13485 and ISO 9001 certification. Capable of coordinating cross-functional teams and managing quality requirements across multiple Asia-Pacific locations.
Highest-signal resume keywords
Quality Management System ProcessesISO 13485 CertificationISO 9001 CertificationRegulatory Requirements IdentificationPost-Market Quality Requirements
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management SystemTransition PlanningQuality Agreements IdentificationCountry-Specific Regulatory RequirementsPost-Market Quality Requirements
Soft Skills
CoordinationCommunication
Certifications & Qualifications
ISO 13485ISO 9001
Industry Keywords
Quality AssuranceRegulatory AffairsSupply ChainCommercial OperationsAsia-Pacific Region
About the role
Key responsibilities & impact- Support regional leaders in transition planning for Quality Regional teams across Asia-Pacific countries
- Perform transition and site-readiness activities at multiple locations in Asia and the Pacific region
- Support identification and implementation of quality requirements for establishing and expanding global quality presence in APAC
- Implement Quality Management System processes in compliance with applicable regulatory requirements
- Support QMS certification, including ISO 13485 and ISO 9001, as appropriate
- Identify when Quality Agreements are required with third-party logistics providers, distributors, and other external partners
- Identify mandatory Quality roles under country-specific regulations
- Identify Post-Market Quality requirements and timing for each country
- Coordinate dependencies and communication with Regulatory Affairs, Supply Chain, Commercial, and Operations teams
- Perform other assigned duties and responsibilities
Requirements
What you’ll need- Support transition planning for Quality Regional teams in the Asia-Pacific region and country-readiness programs
- Experience or knowledge of Quality Management System processes and applicable regulatory requirements
- Knowledge of QMS certification requirements, including ISO 13485 and ISO 9001
- Ability to identify when Quality Agreements with 3PLs, distributors, and other external partners are required
- Ability to identify country-specific regulatory requirements for mandatory Quality roles
- Ability to identify Post-Market Quality requirements and timing by country
- Ability to coordinate with Regulatory Affairs, Supply Chain, Commercial, and Operations teams
- Ability to work across multiple locations in Asia and the Pacific region
Benefits
Comp & perks- Face-to-face collaboration culture
- Equal opportunity employment