(Sr.) Quality System Manager

仕事内容

Respobsibility

• Provide support to internal functions in the application, maintenance and improvement of quality systems, procedures and department specific processes;

• Coordinate external audits by the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings;

• Prepare performance reports and metrics for the QMS, EMS and ISM;

• Ensure efficient and effective processes and tools are established for compliance with ISO standards requirements;

• Serve as the process owner and subject matter expert for key elements of the QMS, EMS and ISM, including CAPA, Complaint Handling and Internal Audit.

• Lead / participate in company-wide internal audit program including planning, implementation, report generation, corrective action issuance to closure;

• Conduct local and global training on key elements of the QMS, EMS and ISM, including CAPA, Complaint and Internal Audit.

• Execute projects and complete other duties as assigned.

Requirment

• Bachelor’s degree in General Business, Engineering, Science or a related field and with a minimum of 5 years’ relevant experience.

• Minimum of 8 years working experience in related field.

• Experience in managing and developing QMS, EMS and ISM in a manufacturing, pharmaceutical or medical device industries.

• Knowledge of ISO International Standards, such as ISO 9001, 13485, 14001, 27001, AS9100, etc.

• Influence management skills; demonstrated ability to work constructively across all functions of the organization, including customers and suppliers

• Excellent communication and presentations skills (articulate and persuasive)

• Strong team management and leadership skills. Ability to create strategies, define and articulate clear role expectations and direction. Willingness to “do what it takes,” including direct auditing activities at times

• Sound organizational and multi-tasking skills

• Risk assessments (e.g. FMEA), Practical Process Improvement (PPI) or Six Sigma experience