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

Key responsibilities include (but are not limited to):

• The Quality Assurance Manager will manage quality systems, processes, and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvement.    
• Accountable for assisting the Quality Assurance Site Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection.
• Responsible for managing quality systems, processes and procedures to assure product quality and safety. 
• Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements  (QSRs). 
• Owns the development and maintenance of policies and procedures for departmental functions.
• Provides leadership and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members.
• Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines.
• Influences participation in compliance to internal and external regulations
• Influences quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics.

Required Qualifications:

• Bachelor's degree  (or high school diploma/GED plus 4 years experience work experience).
• 3 years experience working in a regulated medical device or pharmaceutical environment, quality control/assurance, or regulatory assurance.
• 1 year experience managing people  (if QA Manager will have direct reports).
• Ability to effectively communicate using English  (or local language).
• Must be willing to work in Wuxi.

Preferred Qualifications:

• Demonstrated experience in the medical device or pharmaceutical industry and knowledge of quality system regulations and policies.
• Demonstrated ability to develop  & lead process implementation  & improvement in a team environmen.t 
• Experience with some or all of the following:

1. Design controls, design verification and validation activities. 
2. Production and process controls.
3. CAPA, complaints and risk management.
4. Understanding of product quality improvement using tools such as Six Sigma, DFR.
5. Experience performing internal audits.
    
   

• Demonstrated effective interpersonal and networking skills.
• Prior experience using word processing, spreadsheet, and presentation software.
• Demonstrated ability to successfully comprehend  & carry out/execute actions
• Effective oral and written communication skills.
• Analytical  & problem-solving skills/root-cause analysis. 
• Exceptional conflict-resolution skills.
• Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
• Ability to prioritize and drive multiple programs.