Senior Specialist Quality Assurance
Hologic · Seoul
Senior Specialist Quality Assurance - South Korea
The Senior Specialist Quality Assurance will support Hologic’s Quality Assurance activities in South Korea. This role is responsible for the local Quality Management System, document control, post-market quality activities, adverse event reporting, product release support, and audit readiness.
This role will play a key part in strengthening the local quality framework in South Korea. With the current local QMS still developing, you will help identify gaps, support gap analysis activities with consultants, create and maintain local procedures, and drive document control processes that underpin the wider quality system. Your work will directly support safe, compliant, and high quality delivery of Hologic products and services in South Korea.
What To Expect:
- Support the implementation, maintenance, and improvement of the local Quality Management System in South Korea in alignment with Hologic’s global quality system and applicable Korean regulatory requirements.
- Focus on Quality Assurance activities, including document control, post-market quality processes, adverse event reporting, customer complaint support, audit readiness, and product release activities.
- Support QMS gap identification and remediation activities, working with external consultants and internal stakeholders to complete gap analysis and create new local procedures where required.
- Own and manage local document control activities, ensuring procedures, records, and quality documents are created, maintained, controlled, and aligned with Hologic requirements.
- Own Hologic’s learning environment for the local area, including creating and maintaining the training matrix for the Korean organization and assigning training in HLE.
- Support post-market surveillance activities, including reporting adverse events and overseas adverse events in Korea and submitting required reports to the local regulator.
- Work with US-based teams on adverse event assessments, complaint investigations, and risk assessments as required.
- Partner with third-party logistics and warehousing providers to support product receipt, Korean labelling activities, and product release, ensuring Korean labels are correctly affixed before goods are released.
- Support customer complaint handling activities, including investigation coordination, analysis, reporting, and feedback to management where complaint levels or trends require escalation.
- Review and support product recall, product hold, field action, and correction/removal activities in accordance with instructions from the legal manufacturer and applicable local requirements.
- Act as a local Quality contact for external auditors, Corporate Auditors, and International Quality teams.
- Support internal and external audit preparation, audit responses, and follow-up actions.
- Work with internal teams, external suppliers, third-party logistics providers, and Hologic employees to ensure quality processes meet regulatory and company requirements.
- Maintain awareness of new and developing quality requirements in South Korea and support timely updates to local quality processes and procedures.
- Provide quality input to local operational processes, including sales, after-sales, logistics, product release, complaint handling, and support processes.
- Prepare quality reports, investigation summaries, and updates for management as required.
What We Expect:
- A bachelor’s degree in science, engineering, medical, quality, regulatory, or a related field.
- Strong Quality Assurance experience within the medical device and/or IVD industry.
- Good knowledge of Korean medical device/IVD regulations and post-market requirements.
- Experience supporting QMS, document control, training, complaints, adverse event reporting, audits, and product release activities.
- Strong document control skills, with the ability to create and maintain local procedures and quality records.
- Ability to work independently in a hands-on, operational quality role.
- Strong analytical skills with the ability to identify gaps, assess risks, investigate issues, and recommend practical improvements.
- Effective written and verbal communication skills in both Korean and English.
- Ability to work cross-functionally with local and global teams, suppliers, logistics partners, and auditors.
- Able to manage multiple priorities in a fast-paced and evolving environment.
Why Hologic?
- Work on impactful projects that make a difference in the medical device industry.
- Play a key role in strengthening and building the Quality Assurance framework for Hologic’s South Korea operations.
- Develop your technical quality expertise in a collaborative, global environment.
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