Key Areas of Accountability :

　　Ensure that the Quality management system is established, implemented, maintained, controlled andrecorded in compliance with the International and local regulations and Abbott policies and procedures.

　　Support Country Management in Philippines and Indonesia to ensure compliance with procedures, policies and legal requirements.

　　Implement periodic management review of quality system with country management and report to area.

　　Handle the QH/FA/PI/Recall documents as per relevant procedures.

　　Evaluation, management of Distributors including working with them on the SCARs (Supplier Corrective Action Records)

　　Evaluation, management of Suppliers including working with them on the SCARs (Supplier Corrective Action Records)

　　Primary contact for all external and internal audits, ensure that all findings and related CAPAs are documented and executed per the OACA procedures.

　　Meeting with internal and external stakeholders, Regional and Global teams and other projects.

　　Knowledge & Experience:

　　>8 years experience in a Quality role in Medical Device or Pharmaceutical industry.

　　ISO 13485, GDPMD knowledge

　　Good communication and negotiation skill to facilitate implementation of complex technical solutions and must possess independent decision-making skills.

　　Quality Auditor Certification

　　Ability to travel to Indonesia (<20%)

　　Competencies required:

　　Adaptability

　　Maintaining effectiveness when experiencing major changes in work tasks or the work environment, adjusting effectively to work within new work structures, processes, requirements, or cultures.

　　Teamwork and Collaboration

　　Working effectively and cooperatively with others (especially requiring to work remotely with team in Indonesia), establishing and maintaining good working relationships with internal and external partners to facilitate the accomplishment of work goals.

　　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 [email protected]