职位描述
POSITION SUMMARY（职位概述）
To oversee all aspects of the manufacturing in areas including but not limited to compounding, molding, Assembly, Packaging & steam sterilization. Manages utilization of equipment, facilities, inventory and personnel to obtain maximum efficiency and meet performance objectives. Maintaining, developing, and mentoring the manufacturing team will be a key to meeting performance objectives. Controls significant manufacturing projects and maintain authority over budget and scheduling. Success is realised by guiding the manufacturing organization to meet and improve performance on production schedules, device quality, process controls, product costs and financial goals.
To manage the production from existing ideas, and help to develop new ideas based on your industry experience and your prospects. You must possess a unique blend of business and technical savvy; a big-picture vision, and the drive to make that vision a reality.
Must enjoy spending time in the market to understand their problems, and find innovative solutions for the broader market.
Must be able to communicate with all areas of the company. You will work with an engineering counterpart to define product release requirements.
You will also have the opportunity to develop strategies and multi-year implementation plans for new product introductions and continuous improvement.
KEY RESPONSIBILITIES（主要职责）
1. Supervises employees in the area day-to-day manufacturing operations.
2. Responsible for hiring (with HR input), training, performance evaluation and discipline of employees supervised.
3. Maintains a variety of production records and documents to reflect schedules, performance and procedures.
4. Generates effective communications, good relations, and a positive image with inside customers, suppliers and coworkers, promoting courtesy, objectivity, fairness and teamwork.
5. Ensure that accurate and complete records of department activities are kept, and that they meet regulatory requirements.
6. Develop and monitor production schedules, staffing requirements and budgets. Manage implementation of new processes; technologies, or tolling needed to manufacture products.
7. Facilitate a team based manufacturing environment
8. Support the manufacturing teams in scheduling, problem solving, product quality, employee relations and process improvements to meet the company’s goals and objectives.
9. Ensure that all personnel perform in a safe manner and that an accident free environment is maintained.
10. Develop and monitor appropriate training, training documentation, training policies and training procedures consistent with company and regulatory guidelines.
11. Administer proper floor scheduling to meet master scheduling of product.
12. Provide leadership essential to drive continuous improvement in manufacturing.
13. Direct the organization in a manner in which facilities, procedures, product and employee work practices meet the requirements of ISO, US FDA, GMP, and CFDA regulatory statutes.
14. Authorized to identify and initiate corrective action of non-conformance in documentation, design, equipment, facilities, and processes including those activities covered by the Quality System.
15. Drive and adopt 6-Sigma, Validation and Lean manufacturing concept to continuously improve the productivities and quality.
16. Performs other duties as may be required by supervisor.
SKILLS AND ABILITIES（技能）
1. BS/BA in Business or Engineering is preferred, relevant working experience.
2. Have relevant manufacturing management experience in the medical device and or pharmaceutical fields, more than 10 years’ working experience.
3. Good command of both spoken and written Chinese and English
4. Sufficient software application proficiency in MS office.
5. Extensive manufacturing knowledge including but not limited to inventory/work-in-process principles, labor efficiencies, yield tracking, production scheduling/planning for a high speed, highly automated process.
6. Financial knowledge includes but not limited to budgets, standard costing, variance analysis, fixed and variable costing.
7. Ability to work in a high stress, high productivity and rapidly changing environment.
8. Ability to be a self-starter who identifies, resolves, and reports on issues in timely and effective manner.
