3M Senior Quality Engineer 

South Korea, Hwaseong-si 

761442008

Senior Quality Engineer. In this role, the successful candidate will play a crucial role in ensuring product quality assurance support for Medical Products and management of quality system to meet Korea FDA requirements

The ideal candidate for this position will have a strong background in quality engineering within the Medical Products with a deep understanding of ISO 13485 requirements, Korean Medical Device, Quasi-drug, and Cosmetic regulations. They should possess excellent communication and leadership skills, with the ability to collaborate effectively with cross-functional teams. Strong analytical and problem-solving abilities, along with a commitment to continuous improvement, are also essential.

The Impact You’ll Make in this Role

As a
Senior Quality Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

Working closely with manufacturing, laboratory, and regulatory functional leaders locally and globally, to drive standardization for processes and records related Medical Products. This includes ensuring that all QMS related activities are followed and consistently implemented to ensure compliance with Korea FDA requirements.

Key responsibilities of the Senior Quality Engineer will include:

• Enhancing Customer Satisfaction – Implement quality activities aligned with division quality strategy to enhance customer satisfaction.

• Quality System Leadership – Establish and maintain the quality management system in Korea for Medical Device, Quasi-drug, and Cosmetics.

• Leading Quality Qualification in New Product and Product Change Projects - Ensure new or modified products to meet customer, regulatory, marketing requirements.

• Resolving Quality Issue – Lead the communication between lab and plant to minimize the lead time to resolve the issue and complaint sample analysis.

• Supplier Product Quality Management – Establish supplier product quality plans to ensure the outsourced product to meet its requirements.

• Product quality – Support product quality such as design issue follow-up, sampling plan revisit for product release, document revision, etc.

Your Skills and Expertise

To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

• Bachelor’s degreeor higher in an engineering or sciencediscipline (completedand verified prior to start) from an accredited institution

• Three yearsof combined experience ina Manufacturing,Production, Quality and/orLaboratory role in a private, public, government or military environment

• 5 years of Experience in Medical Device industry

Additional qualifications that could help you succeed even further in this role include:

• Bachelor’s degree or higher in a Science, Technology, Engineering or Mathematics (STEM) or related discipline from an accredited university

• Experience in Medical Device QMS – ISO 13485, MSAP, MDD, Korean FDA regulations

• Certifications in quality engineering, quality auditing or quality management according EOQ standard or comparable

• Microsoft Office proficient

Condition

• Type: 정규직 (수습기간 3개월)

• Location: 한국3M 동탄 기술연구소 (경기 화성시 삼성1로5길 7)

Application Guidelines (입사 지원 시 주의사항)

• Click ‘Apply ’ button

• Fill in basic information such as employment ?and education

• Upload your both of Korean/English Resume (merge your files into one file )(이력서 내 경력기술서 및 자기소개서 포함)

Others

• 해외여행에 결격사유가 없어야 합니다.

• 국가유공자 및 보훈대상자(veteran) 은 관련 법규에 따라 우대 합니다.(지원 시 Veteran 관련 질의에 YES 선택)

• 장애인(Disability) 은 관련 법규에 따라 우대합니다.(지원시 Disablity 관련 질의에 YES 선택)

• 채용과정 중에 제출하신 서류에 대한 반환을 청구하실 수 있습니다.(단, 온라인접수/전자메일로 제출된 경우나, 구인자의 요구없이 자발적으로 제출한 경우에는 제외됩니다.)

• 허위사실 기재 시 채용 취소됩니다.

• 모든 지원자분들께 결과 안내를 드리고 있습니다. 다만, 각 전형별 합격자에게 우선 안내해 드리는 점 양해 부탁드립니다.

• 제출해주신 이메일/핸드폰번호로 연락드리니 정확한 기재 부탁드립니다.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

Please access the linked document by clicking select the country where you are applying for employment, and review. Before submitting your application, you will be asked to confirm your agreement with the terms.