Job Description

Duties & Responsibilities

• Implement, manage and improve a quality system in accordance with HOLOGIC harmonized quality system and comply with other governmental and environmental regulations on a national scale which apply to HOLOGIC International marketed products and services.
• Work with internal staff, external suppliers and HOLOGIC employees to ensure quality processes meet regulatory and company guidelines.
• Fulfils the role of HOLOGIC Management Representative of the Quality system, ensuring that executive management is informed of QA issues or identified potential risks and that appropriate actions and resources are applied to quality and compliance concerns.
• To define, implement and manage quality initiatives both internally and to end users and distributor group.
• Provide direction for internal processes improvement, including sales, after sales and support processes and assist Business Management for implementation.
• Responsible for internal audits, customer complaints management, document control, quality control inspection and product release activities.
• Maintain awareness of new and developing quality trends and requirements. Ensure timely establishment and ongoing validation of processes and systems to maintain requirements.
• Act as primary contact for International Quality and auditors with the authority to initiate significant changes to policy and procedures if required to ensure compliance.
• Coordinate any removal and correction of product/devices in distribution.
• Initiate product hold in accordance with instruction from the legal manufacturer.
• Manage Customer complaints reporting system providing analysis, investigation, reports and feedback to management and customers as required
• In collaboration with functional leaders, create and maintain a training matrix.
• Manage Hologic online training system and assign training to all staff in accordance with the training matrix.

The Person

The successful candidate will have in-depth understanding of the Korean medical device and IVDs industry environment. He / She must be able to work independently, as well as within a team, and excel within a results-oriented environment where quality activities must be executed timely and accurately. Strong communication skills, with proficiency in communicating strategic and tactical issues to management and ability to influence. He / She must be highly accountable and be able to multi-task and prioritize.

In addition, the successful candidate will possess:

• Proven experience of implementing quality initiatives in a Direct Market organisation.
• Excellent communication skills with ability to effectively interact at all levels as well as cross-cultural awareness. Work well with cross-functional teams.
• Able to work under pressure and in an ambiguous environment.
• Prioritize and manage multiple, simultaneous tasks.
• Demonstrated strategic, conceptual, and analytical skills, including a solid understanding of relevant regulations and standards.
• Multi-national company experience with specific success working for US or European based companies.
• Friendly, good attitude, customer oriented.

Qualification & Education

• A bachelor’s degree in science, engineering, medical or related field.
• Minimum 8-years of relevant experience working in a QA role within the medical device industry.
• Good knowledge of Korean medical device industry and relevant regulations.
• Effective oral and written communication and presentation skills in both Korean and English.