Quality Assurance Specialist

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The PositionAffiliate: Roche Diagnostics Korea Division:Regulatory & Quality Work location: Seoul, South Korea Your key responsibilities 1. Ensures that all Roche products handled by RDKR are being distributed & controlled in compliance with Roche quality policy and with all relevant regulations in Korea. 2. Performs a variety of QA Specialist duties from the post-market care point of view to ensure requirements are met. 3. Reviews, analyzes and reports on product safety issue related to all Roche products handles by RDKR (1) Quality Management System - Develops and implements RDKR QMS harmonize with Roche global quality policy and relevant Korean regulation and standards. - Support internal audit preparation and participate in the planned audits - Ensures that quality of products conform to established DMR and regulatory standards. (2) KGMP - Manage KGMP submission and get certification within the declared timeline for the assigned sites to ensure business continuity and product supply - Align KGMP preparation process in QA team to reduce communication confusion with GRA and improve the process (3) Management of Product Safety & Post-market care - Perform a variety of duties in ensuring product safety and post market care in compliance with Korean Enforcement Regulations of the Medical Device Act, such as safety & quality notification management, vigilance, recall etc. - Document and Manage labeling documents (label/IFU/DMR) according to the registration status to ensure importer quality compliance - Coordinate the Promotional Material Review Process and perform QA reviewer role to ensure deliver promotional materials in compliance with regulations - Register chemical products and monitor the status incl. DGs, Toxic chemicals, etc. (4) Conduct business in full compliance to Business and Behavior in Competition Who you are 1. Education & Qualification - Bachelor degree or above in related field. (Medical engineering or electrical engineering is preferred.) - Familiar with related local and international regulations and standards - Fluent English both spoken and written - Good skill in computer software (i.e. MS word, Hanguel, excel, etc.) - General knowledge of other related disciplines 2. Experience - 5+ years of related experience (Medical Devices QA experience is preferred.) - Good relationship with government authorities and officials 3. Competencies - Communications skills, both oral and written at all levels of the organization - Attention to detail - Data collection, management and analysis - Problem Analysis and Solving - Teamwork Submission (제출 방법) 자유 양식의 국/영문 이력서 및 국/영문 자기소개서 (하나의 MS Word 혹은 PDF 파일로 제출) ※ 이력서 상단에 반드시 현재 연봉과 희망 연봉을 표기하시기 바랍니다. 누락 시 이력서가 검토되지 않습니다. ※ 이력서 내 이메일 주소와 서류전형 지원 사이트의 입력하시는 이메일 주소를 반드시 동일하게 작성해주시기 바랍니다. ※ 국가보훈대상 및 장애인은 관련 서류 제출시 관련 법규에 의거 우대합니다. ※ 이력서에 개인민감정보 (신체적 조건, 출신 지역, 혼인 여부, 가족관계 등)는 기재하지 말아주십시오. ※ 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후 라도 채용이 취소될 수 있습니다. Next step (다음 전형에 대한 안내) 서류 전형▶ 면접 전형 ▶ 종합 심사 ▶ 최종 합격 통지 ※ 면접은 서류전형 합격자에 한해 개별 통보합니다. ※ 면접 일정 안내 및 조율을 위해 해외 번호(중국)로 연락이 갈 수 있는 점 미리 안내드립니다. ※채용이 유력한 후보자에 대해서 이력 검증 및 평판 조회, 건강검진 등의 종합심사를 진행하여 최종 합격자를 선정합니다. Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.