北京招聘

JOB SUMMARY

Responsible for providing leadership and technical support to assure quality compliance related to all supply chain QA and Quality Management System (QMS) activities within APAC.

This function delivers the implementation of quality to ensure capability for operations and distribution. This will be applied through assuring compliance with international and corporate supplier management and QMS processes and any other applicable regulatory requirements.

This role manages the development, implementation, and maintenance of the APAC Quality Management System, which includes the functions of management controls, Internal Audit, Corrective/Preventive Actions and Supplier Quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provides leadership, technical support, and ownership to all aspects of supply chain quality and QMS in APAC to address compliance and/or product related quality issues through daily interactions with logistics, distribution, and service.

• Responsible for technical investigations plans, reports and related procedures which ensure validity, adequacy, and compliance of the logistics and distribution process to regulatory and corporate requirements.

• Supports risk assessments and implementation of risk control measures related to distribution and logistics processes.

• Implement all GDP (Good Distribution Practices) to all logistics supply chain of all Hologic and third-party products within APAC.

• Supports Supply Chain center of excellence group in the creation of documentation associated with quality supply chain activities including but not limited to: supplier agreements, supplier files, and supplier assessments/audits.

• Communicates current and applicable regulations applicable for the logistics, distribution, reverse logistics, and service of Hologic products.

• Manages the generation and reporting of supply chain quality KPI’s.

• Ensures that Quality Management System requirements are effectively established and maintained. Manages the Quality Assurance group activities with regards to Management Controls, Document Control, CAPA, Internal Audits, Supplier Quality and Nonconforming Events.

• Partners with Senior Director, RAQA APAC in the execution of APAC Management Reviews.

• Partners with Senior Director, RAQA APAC to manage audits/inspections from Notified Bodies and/or regulatory agencies. Developing responses to any corrective actions required. Performs follow-up audits to assure agreed upon corrective actions have been implemented.

• Ensures and owns execution of activities to support change control activities and document management requirements by collaborating with applicable departments and peers to define requirements for individual projects.

• Attend and lead regular communication meetings with cross-functional teams to identify the root cause of problem and create corrective action plans for short-term and long-term resolutions.

• Supports the delivery of system solutions by assuring activities are conducted in a compliant but cost-effective manner. Works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations.

• Manages the APAC Quality personnel through goal setting, task assignment and review of performance.

• Perform other related duties as assigned.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPERIENCE

BS or equivalent in scientific discipline, engineering, or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 10 years’ experience in supply chain quality and Quality Management Systems environment in the medical device or pharmaceutical industries.

• Must be proficient in the knowledge of applicable regional regulations, APAC regional/country (e.g. Japan, China, Korea, Australia, New Zealand) Quality System Regulations and ISO quality requirements (9001 / 13485)

• Must have advanced knowledge of supplier quality requirements and advanced knowledge in Good Distribution Practices

• Experience with logistics and distribution processes is preferred in particular, cold chain management, dangerous goods and oversized product management

• Proficient in spreadsheets and word processor applications

• Proficient in concepts of statistics, sampling plans and statistical analysis

• Ability to independently plan, execute, and/or problem solve moderate to complex situations

• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

• Must demonstrate leadership attributes

• Solid oral and written communication skills

• Ability to manage multiple projects

• Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation

• Computer literate - knowledge of Word, PowerPoint and Excel an advantage - to produce reports, analyse data, etc. effectively

  PHYSICAL DEMANDS

• Flexible working hours and travel is required for business requirements

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

ACCOUNTABILITY

• Responsible for ensuring that related supplier quality activities comply with current regulations
• Team achieves site and company goals and objectives
  

Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
There’s never been a more exciting time to join us.
豪洛捷是一家领先同侪，集研发、制造和供应优质分子诊断产品和服务、医疗影像系统、外科手术产品于一体的公司，以服务全球***医疗健康需求为己任。豪洛捷公司致力于通过早期诊断、微创的治疗方式帮助全球***得以享受更健康、更长寿的生活。目前hologic亟需优秀人才的加入。

Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
有远见的人一起致力于健康诊断成就了今天的Hologic。我们坚信，人才是公司宝贵的财富，只有通过招聘、培训、发展、保留***的人才，我们才能持续成功。

Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
我们的工作氛围是促进创新和以客户为中心。我们为员工提供***的工具和技术，合作和充满激情的工作环境，以提升世界各地的医疗保健水平。

We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues.
公司总部位于马萨诸塞州，在北美、欧洲、拉丁美洲、澳大利亚、亚洲设置了运营中心。我们将集中公司资源致力于提升全球的健康水平。

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today.
我们正在迅速成长，我们将更加关于于人民、成长与未来。这是一个激动人心的历史时刻，可以访问我们的网站以了解更多的职业生涯的机会。

Hologic has commercial organization, R&D, MFG facilities in China. China Headquarter is in Beijing. We aim to build China Organization an exciting place to work and grow professionally.
豪洛捷在中国设置了完整的商业机构，包括研发、生产等。总部位于北京，我们致力于打造积极的、专业的商业运营机构。