Company Background:
Our client is a well-known MNC company in various technology and services industries.

Description:

As a member of it global quality compliance audit staff, the auditor will conduct comprehensive reviews of it businesses' activities including performing and documenting audits as well as providing follow-up activities to ensure compliance with regulations and conformance to written, approved procedures for production and facilities. 

Key responsibilities include:

• Identifying non-conformities with IT Quality Management System (QMS) or applicable regulations
• Provide direction on root cause investigations for issues impacting process quality.  
• Proactively assess risk, plan and execute audit deliverables.
• Communicate audit results and recommendations to senior management.  Create and drive business wide improvement efforts to improve systemic challenges.
• Interface with senior management and external regulatory agencies and partners during inspections, audits, investigations and report-outs as necessary.
• Assist local operational quality/compliance representatives to perform gap analyses to identify compliance risks, develop action plans, report progress and ensure closure. 

Qualifications:

• Bachelor's degree with operations, engineering, or quality experience in regulated chemical, electronics or medical products industry; OR minimum of 6 years experience in engineering, operations or quality supporting medical devices.
• Experience with internal or external quality system audits.
• Knowledge and understanding of quality systems.
• Ability to travel globally to perform audits as needed; up to 35% travel with sometimes little notice.  
• Prior experience using spreadsheet and presentation software.
• Working knowledge of English language (oral and written).

Preferred Qualifications:

• Experience in QA in Medical Device & Pharmaceutical industry, knowledge of QSR/ISO 9001/ISO 13485 affecting medical devices.
• Strong process improvement mindset, passion for quality.
• Strong strategic business perspective and systems thinking capability.                
• Excellent verbal and written communication skills, interpersonal skills, strong analytical skills, and the ability to manage complexity.
• Certified auditor or lead auditor (i.e. ASQ certification). 
• Thorough understanding of it procedures.
• Knowledge and exposure to Lean Six Sigma tools.
• Experience with high volume manufacturing and/or medical device design.