职位描述
As the Quality Compliance Manager you will support the global QMS and Compliance affairs for international medical device manufacturing facility, principally with ISO13485 standard and 21 CFR 820 regulations and by preparing analysis and monitoring of conformance of regulatory guidelines for the company.
Primary Responsibilities
• Support Quality Manager with Compliance Monitoring and support the implementation of the monitoring programs;
• Provide support and assistance to business to ensure the business monitoring plans of specified operations within each focus area are developed and executed as required;
• Conduct appropriate follow-up and periodic monitoring activities to ensure remediation and corrective action plans are implemented and carried out;
• Collaborate with internal departments to support and continuously enhance Compliance Monitoring and training;
• Effectively utilize various technical applications, navigating through various data systems, gathering and analyzing data from multiple relevant sources in order to identify trends, patterns of non-compliance and or gaps in established key controls, processes and/or procedures;
• Establish credible cross-functional business relationships to ensure collaboration, adherence to and maintenance of established work programs and processes;
• Support timely and effective communication and implementation of any new deliverables based on the outcome of monitoring, investigations, risk assessments and corrective action remediation plans.
• Support investigations of reported compliance related issues and help ensure internal investigations are conducted timely and according to established policy and standard processes;
• Collaborate with the business departments to support internal audit preparation and remediation actions, and effectively communicate audit observations and best practices;
• Effectively share and communicate monitoring observations, support the development of plans with Quality Manager;
• Perform other duties as assigned.
The successful candidate will have:
• 3+ years of hands on experience with quality compliance, preferably within medical device manufacturing.
• Hands on experience with ISO13485 and 21 CFR 820 regulations
• Must be Bi-lingual English and Mandarin, written and spoken
• Excellent written and verbal communication skills
• Proficient with computer programs, Word, Excel, etc.
