핵심 정보
- 경력
- 경력 7~13년
- 학력
- 대졸(4년제) 이상
- 근무형태
- 정규직
- 급여
- 면접 후 결정
- 직급/직책
- 과장, 차장, 부장
- 근무일시
- 주 5일(월~금) 08:30~17:30
- 근무지역
- 서울 금천구
본 채용정보는 마감되었습니다.
커리어서포트에서 채용공고가 시작되면 이메일로 알려드립니다.
상세요강
1. 포지션
- Quality System
Engineer (Korea Filtration
Division)
2. Essential Functions:
1) Improve processes base on ISO 9001, ISO 22000, ISO 13485, FDA, Pharmaceutical
and Biotechnology standards, practices and previous knowledge and experience.
2) Develop, implement and report the internal quality system audit and
mock audit program with Division personnel against ISO 9001 and Halal.
3) Participates the audit processes, both internal and external
(customer, certification and regulatory bodies) to identify opportunities for
continual improvement.
4) Provide support for the control of national and international
standards library to ensure that the most up to date revision is always
available at the point of use.
5) Implements performance measurements necessary to effectively
evaluate organizational performance and trends in product quality, service,
RPPM, COPQ and customer satisfaction. Uses the results of performance
evaluation and audits to target improvement efforts.
6) Carry out or complete any activities required to support the needs
or requests from customers and regulatory authorities. For example, audits,
questionnaires, agreements, etc.
7) Quality & Customer Interface: Maintains system a
corrective/preventive actions to analyze and correct nonconforming conditions
and complaints.
8) To review a plan of change controls and verify its changes with the
necessary objective evidence.
9) Validation: Develops validation plans and protocols for the
qualification and validation of existing and new equipment, manufacturing
processes and products. This could extend and link into facilities, utilities,
cleaning and software.
10) Provide necessary support to make sure the effective running of
manufacturing site/Laboratory calibration, maintenance and training systems.
11) Provide quality management software systems, regular cGMP training
and related quality training to all relevant employees across the site as
needed.
12) Provide support and guidance as needed for the cleaning, calibration
and pest control contractors.
13) ISO 22000 / HACCP Certification Promotion Leader and Support /
deputize other certification such as Halal.
3. Qualifications
1) Qualifications: 4 year college degree in Industrial engineering,
Chemical engineering, Biology or related department required with certification in quality management
preferred.
2) 7~13 year's experience working within a Life Sciences, Medical
Devices and/or Pharmaceutical style of quality system, along with detailed
knowledge of gaining, maintaining and developing ISO 9001, ISO 13485 and ISO
22000 processes and procedures.
3) Must have experience of working with an electronic quality
management systems software to assist with the development of practical systems
using certain quality management systems software.
4) Have experience working as supplier auditor in Life Sciences,
Medical Device and/or Pharmaceutical company for initial Supplier Quality
Systems audit, which will cover all aspects of the operations associated with
the manufacturing processes and practices for the following filters from
material receipt to finished product release.
5) Has experience of working with an electronic quality management
systems software to assist with the development of practical systems using
certain quality management systems software.
6) Possess analytical and technical skills required to understand
business practices and recommend proper opportunities.
7) Excellent written, verbal, and interpersonal communication skills
for effective interface with all internal and external contacts.
8) Prefer to have practical hands-on experience of six-sigma (to at
least Green Belt level) and Lean Manufacturing and all its supporting tools,
e.g. 8D, statistical studies (SPC, capability, stability, R&R, etc),
Validation and Failure Mode & Effects Analysis, along with the ability to
train and educate personnel in these tools..
9) Fluent written and verbal in English skills preferred.
4. 처우조건 : 이전 연봉 이상으로 협의
5. 전형절차 : 서류전형 후, 면접진행
6. 제출서류 : 국영문이력서, 자기소개서, 경력기술서
7. 회사위치 : 경기 화성
8. 연락처 : (02)6332-6346 / ktpark@c-support.co.kr
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