湖州招聘

Job Summary

The overall responsibility of this position is to manage group quality functions and regulatory affairs, which include regulatory compliance, developing quality standards / requirements, quality planning, reporting, procedure development, processor implementation of company quality strategy, quality education, ensuring quality systems and processes are in full alignment with QSR820, GMP, ANVISA, ISO13485, company expectations and other applicable requirements, ensuring new product development is effectively managed by usage of qualification protocols, assisting with supply chain management and working with management to develop, optimize and execute policies creating a clear vision and the execution of a results-driven Quality Management System, which will create business-wide improvements.

Key Position Responsibilities

• Lead and develop regulatory compliance, registration, quality assurance, quality engineering and quality control teams pursuant to QSR, GMP, ANVISA, ISO13485,international and corporate regulatory requirements and standards;,
• Lead and develop complex world-wide regulatory and quality strategies
• Establishment of a solid quality system of Company group and continuous improvement to ensure the world class RC/quality performance
• Responsible for implementation of Quality Policy
• Lead and develop regulatory assessments and strategies in support of new product initiatives and product line extensions
• Lead and/or guide the customer complaint handling process
• Monitor changes to domestic and international regulations and standards & assess impact on company / clients
• Lead regulatory submissions worldwide
• Provide regulatory intelligence information to the organization
• Provide Daily Support to Product Regulatory Teams
• Provide an independent review of deliverables assigned to other RQS staff to ensure high technical quality that will meet customer and regulator expectations
• Be responsible for internal and external quality audit
• Develop and lead regulatory compliance and quality training to organization
• Manager supplier qualification and regulatory compliance/quality performance
• Lead and develop Quality System Plans

Experience

Skills and Abilities (Can Do Criteria):

§ Bachelor’s degree or above, MBA is a plus

§ Knowledge of manufacturing is required;

§ Strong background and experience in quality and regulatory management

§ 8+ years experience in healthcare industry; familiar with QSR820, GMP, ANVISA, ISO13485, etc.

§ Good command of English in both speaking and writing; good level of computer skills, e.g. MS Office tool;

§ Good understanding of quality and regulatory system;

Personal Traits (Will Do Criteria):

§ Professional and ethical conduct

§ Attention to details, task focused and result-driven

§ Excellent all round communication skills

§ Committed to continuous improvement

§ Excellent team player and coordinator.

Job Environment

§ Hi tempo, high pressure in a multi-cultural environment with real challenges

Contacts/Involvement:

§ Liaison with other Company manufacturing sites in China and USA

§ Co-ordination and communication with government, customers and other functions in the China facility

Job Satisfaction Potential

Satisfaction:

§ Opportunity to help deliver the new projects on time and to enhance the Company manufacturing facility in China.

§ Opportunities for further career development.

Potential Dissatisfaction:

§ Balancing cultural, deadline, production and quality challenges

Development Perspective

§ An opportunity to further develop ones technical, cultural, communication and management skills, in a controlled project environment of the highest visibility and importance.