Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position
The position is responsible for quality management activities, including but not limited to site registration, quality records management, local labeling management. Also responsible for managing and implementing necessary measures to comply with the Intuitive Quality Manual and related internal procedures under ISK Quality Management System (“ISK QMS”).  

Closely collaborate with Regulatory affairs, Commercial, Customer Service and SCM.  

Essential Job Duties

Regulatory compliance & QMS management

• Support internal QMS monitoring
• Follow up all post auditing activities and drives the execution of corrective action and preventive action, ensuring the timely closure of CAPA/ARF actions.
• Closely communicate with regulatory agencies to seek resolutions on quality issues or formal disputes that may arise.
• Manage local IFUs archiving process and conduct regular internal labeling monitoring
• Review & approve product release, return, scrape, preowned device report and manage the related records to comply to the local regulations, ISK QMS and Global guidelines.
• Regularly train 3rd parties involved in quality activities to ensure the GSP compliance.
• Cooperate with Safety control team to assess the product complaints and reduce the product complaints
• Participate in local or global quality efficiency improvement projects.

Site registration

• Support all procedures of site registration including new site registration, change management, renewals, after-approval administrative work precisely and efficiently, including strategy set up, compiling submission dossier, communication with the responsible health authority/notified bodies, safety stock building in cooperation with responsible functions, documents archiving, reporting, etc.
• Support or manage on-site or desktop audits.
• Provide regulatory input to stakeholders within ISI & ISK to support business planning, product stock management, etc

Qualifications

Required Skills and Experience

• Preferred >3 years of relevant RAQA experiences in the medical device industry.
• Knowledge of Korean Medical Device Act & related regulations/guidelines and ISO13485
• Preferred experiences in supporting GMP on-site audit on foreign sites.
• Excellent verbal and written communication both in English and Korean & interpersonal skill to work well with cross-functional teams
• Ability to foresee regulatory challenges and develop critical concepts and methodologies to overcome these.
• Ability to work in a fast-paced environment and handle multiple projects simultaneously
• Ability to distill complexity and provide clear and actionable direction.
• Orientation for work result details, with emphasis on accuracy and completeness

Required Education and Training

• Bachelor’s degree in science, engineering, medical engineering or related
• In-depth knowledge of Korean medical device act & regulations, ISO13485

Preferred Skills and Experience 

• Experience in SAP, Track Wise

Additional Information

Intuitive는 고용 기회 균등 고용주입니다. 당사는 인종, 성별, 임신 여부, 성적 지향, 성 정체성, 출신 국가, 피부색, 연령, 종교, 국가 보훈 대상자, 장애 여부, 유전 정보 또는 연방, 주 또는 현지 관련 법률에 따라 보호받는 기타 모든 지위에 관계없이 자격을 갖춘 모든 지원자 및 직원에게 동등한 고용 기회를 제공하며 모든 유형의 차별과 괴롭힘을 금지합니다.

당사는 기회 균등법에 따라 범죄 및 유죄 판결 기록이 있는 고용 자격을 갖춘 지원자를 고려할 것입니다.

Shift: Day