QA Manager--某全球知名欧美医疗公司

Key Responsibilities:
? Responsible for executing a China Quality system for products from different divisions and businesses .
? Define, implement and execute effective Quality strategies and processes for Company Scientific the goal of exceeding compliance, minimising risk and maximising commercial opportunities.
? Design and redesign the connection points, information flow, decision flow, material flow, roles and responsibilities, and supporting SOPs that will better enable the China commercial operation to deliver quality into the experience of our clinical customers.
? Drive standardized work and timely flow of information, decisions, and communication about product quality.
? Establish and maintain a closed-loop complaint handling and post-market surveillance system.
? Lead improvement initiatives across the business that will enhance organizational compliance and improve employee awareness around the quality function.
? Proactively partner with key business stakeholders to understand key business matters and any areas of impact from a quality perspective.
? Pro-actively identify potential quality and compliance risks
? Performs other duties as assigned
Minimum Qualifications:
? 10+ years experiences in in the field of quality management, prefer in Healthcare/ biotech / chemical/ Life science industries
? Highly motivated and dependable, with good communication skills and a quick learner, a team player.
? 8+ years of experience operating under ISO-13485
? Strong English and general communications skills in both written and verbal communication
? Experience of enterprise software systems (eg SAP, Master Control, Trackwise etc) and MS Office tools (Excel, Word, Project, Visio)
Preferred Qualifications:
? 10+ years employment in commercial operations with a strong compliance track record in China,
? Experience in large company (Multinational/Chinese) environments
? Experience building a quality system and establishing a quality culture.
? Knowledge and track record of continuous improvement
Skills and Attributes:
? Organisational skills with an ability to prioritise manage time effectively and meet agreed deadlines;
? Effective interpersonal, communication and listening skills;
? Dedication and commitment towards a professional and positive attitude to work;
? An ability to think strategically and laterally in order to maximise business opportunities;
? An initiative taker willing to work autonomously;
? An enthusiastic, energetic and positive attitude;
? A supportive team player; and the ability to create and foster meaningful and beneficial partnerships with peers, suppliers and customers.