宁波招聘

职位描述：
BASIC PURPOSE OF THE POSITION
This position is responsible for leading, directing and coordinating internal laboratory and managing the APO on supplier regulatory compliance. Position also responsible for products registration of medical devices, and FDA compliance for products. Implements and maintains local quality systems in APO. Ensuring all documentation regarding Engineering Change Notices (ECN) is updated.

PRINCIPAL ACCOUNTABILITIES
? Knowledgeable of all scope for all testing processes under supervision
? To develop and execute Regulatory compliance strategic management for cost effective operation
? Performs Budget management and control for the department
? Responsible for products licensing and corresponding KFDA, TFDA, SFDA & other AP regions rules and regulations compliance, monitoring and implementation.
? Responsible for company sites and products registration to international and domestics markets for medical devices. Preparation and submission of product registration in Health Department and support for international registrations to align with company strategies. Interact and negotiate with FDA in cases of incidents.
? Ensure that all aspects of the handling, manufacturing and distribution Medical Device are in compliance with the local regulation in AP.
? Manage all critical quality issues（complaints, recalls, and stability failures, etc）according to the Quality Agreement and the Quality Manual. Ensure investigations and CAPA are correctly executed.
? Maintain knowledge of new regulatory requirements on a global basis and best practices related to quality processes
? Report the supplier’s audit status to management team by regular meeting.
? Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for ISO13485 system in the company
? Provide compliance training to lead auditor
? Ability to create and make revisions to test plans for laboratory activities
? Responsible for improvement and upgrade to laboratory facilities, monitor and report laboratory utilisation in terms of equipment and personnel, scheduling of testing activities and maintains test plans/ instructions in the laboratory
? Responsible for working with global BUs and laboratory to increase testing work in APO laboratory
? Leading the production of test reports, monitoring the certification/ recertification activities
? Provides and manages the necessary resources (personnel, equipment, resources, etc) for the laboratory testing program, in order to ensure confidence in the laboratory’s result
? Ensures equipment is maintained & calibrated, reporting all deficiencies in the appropriate manner
? Ensures personnel are trained for the duties they perform. Leads the budget and management of the laboratory
? Suggest new testing requirement and method with engineering team , design new testing fixture for endurance testing
? Manage external laboratory testing activities
? Leading engineering documentation control, ensures revisions are updated and leads the training on usage of Agile
? Leads Project Planning and Management – Identify and define current business process throughout the lifecycle of a project while focusing on regular and timely delivery of value; organize and lead APO based initiatives in collaboration with EP Core team to improve and enhance PLM project status.
? Organizing and working with APO team; prepare and distribute progress reports to Agile PM (EP); manage risks and issues; solution ways to utilize Agile and alleviate waste; perform delivery planning for assigned projects
? Team Management – Assist in team development while holding teams accountable for their commitments, removing roadblocks to their work; leveraging organizational resources to improve capacity for project work; and mentoring and developing APO team member
? Process Management and Improvement – Assist EP Core team with a well-defined and evolving project management process; APO lead will recommend, communicate, and execute process improvement initiatives submitted to EP Core based on best practices.

EXPERIENCE OR SKILLS REQUIRED
? Min 15 years relevant experience in regulatory field for medical device with min 5 / 10 (SNR) years in management role (MNC preferred)
? Strong knowledge in KFDA, TFDA and SFDA rules and regulations, FDA, QSR and ISO13485
? Familiar with international standards such as EN, IEC, UL, etc, also customer performance requirement
? Experience to work in laboratory or 3rd party agency, preferably in manufacturing industry
? Knowledge of the full spectrum of laboratory functions
? Ability to be a confident business partner and build and maintain continuous relations with external consultant & 3rd party agency
? Strong managerial & leadership skills
? Adaptable to a changing and fast paced environment
? Possess excellent interpersonal and good communication skills
? Good team player, possess strong analytical skill and project management, and with effective in communication
? Good command of both spoken and written English and Chinese / Mandarin 举报 分享

Helen of Troy (*******************, NASDAQ:HELE) incorporated in Texas in 1968 and were reorganized in Bermuda in 1994. We are a leading global consumer products company offering creative solutions for our customers through a diversified portfolio of well-recognized and widely trusted brands. We have built leading market positions through new product innovation, product quality and competitive pricing.
We have three business segments:
Housewares. Provides a broad range of products to help with food preparation, cooking, cleaning, organization, beverage service, and other tasks to ease everyday living for families. Sales for the segment are primarily to retailers, with some direct-to-consumer product distribution.
Health and Home. Provides healthcare and home comfort products. Sales for the segment are primarily to retailers, with some direct-to-consumer product distribution.
Beauty. Provides personal care, beauty care and wellness products including hair styling appliances; grooming tools; decorative haircare accessories; and liquid-, solid- and powder-based personal care products. This segment sells primarily to retailers and beauty supply wholesalers.

We are a dynamic, growing company that offers challenges and opportunities equal to your talents and abilities. If you’re seeking an exciting, professional position in a company that allows outstanding performers to achieve their potential, Helen of Troy will be a great choice for you.