Main Responsibilities:*

• Responsible for managing all quality affairs activities for Taiwan and Hong Kong for ADC.

• Act as Tai Wan and Hong Kong QA lead

• Manage the routine Quality Assurance operations within the Affiliates for ADC and responsible for development, training, implementation and monitoring of quality systems for ADC Tai Wan and Hong Kong.

• Maintain a good relationship with TFDA and HK DOH

• Establish and aggressively drive the Quality Assurance strategy for Tai Wan and Hong Kongby taking ownership and aligning with key Global ADC Quality strategies and direction.

• Ensure consistent application of relevant Quality Assurance policies, programs, and systems by clearly defining specific Abbott and Abbott Diabetes Care SOPs and locally developed procedures that govern critical to success business functions. Recognition that some degree of flexibility to execute activities appropriate to local requirements and market needs is also required.

• Elevate issues or significant events (product performance issues) to the appropriate facility with relevant fact. and details enough to allow Subject Matter Experts responsible for the product quality and performance to analyze, investigate and provide feedback and corrective actions appropriate to the issue.

• When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, formulate detailed action plans that integrate identified stakeholders, the actions necessary and the required methods and timelines to successfully correct the problem and prevent the issue from recurring / occurring. Ensure CAPAs identified during audits or other means are successfully resolved prior to committed due dates.

• Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Respond to manufacturing site requests (eg quality holds, reworks, complaint product returns).

• Organize and develop timely action plans in close coordination with the Regional Customer Service Manager ensuring a seamless execution of successful QA strategies for Tai Wan and Hong Kong

Skills & Experience Required:*

• BS degree in medical device/engineering or related fields.

EXPERIENCE /QUALIFICATION

• Minimum 5-year experience quality assurance in medical device, pharmaceutical or related industry.

• Previous experience should demonstrate the ability to prepare product registration documentation

• Familiarity with the Taiwan and Hong Kong Medical Device Laws and related regulations and regulations such as ISO 9001/ISO13485, QSR,etc.

• Effective communication and coordination skills

• Proven project management skills

• Good command of written & spoken English and computer software skills

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com