(Bilingual – English and Mandarin preferred)
Are you a leader who has a consistent high energy, an exceptional level of organizational skills, with a perennial “can-do” attitude and displays professionalism at all times? Do you strive for excellence in every function and responsibility of your professional career? If you think you have what it takes, then please apply today!
As the Project Manager (PM), you will work on contract manufacturing projects assigned by the Director of Operations. You’ll ensure the customer programs/projects are fully executed on time, within budget and bring any major issues to plant management and Strategic Business Units when they arise. We’ll rely on you to evaluate if Amsino is equipped to perform the project and any capital requirement needed for each program.
Facilitate and coordinate assigned programs or projects. Develop an overall project plan for each program and organize with project teams to define goals, identify, assign tasks, and delegate action items and follow-up/track action items for resolution.
Coordinate with Regulatory consultant and Amsino Quality teams that all documentation, functional testing, validation protocols and results are provided.
Follow plant SOP’s procedures for executing programs. Develop project plans using MS Project, smart sheet, and Project Tracking and Action forms that can be understood both internally and by the customer.
During the execution phase, track profitability changes if any and project costs.
Ensure quality and other specifications by customers are met. Develop final product inspection criteria for the product to be manufactured. Adhere to and comply with cGMP, FDA, ISO, environment protection rules and regulations
Set up routine meeting / conference calls with customer and project teams for status updates and address any project needs.
Conduct cost analysis for new projects to ensure these projects are profitable.
Set up technical specification, SOP’s, and specifications for old and new products. Provide technical information to the QA team for MDR (Master Device Record) and DHF (Design History File)
Travel to customer and Amsino plants as needed.
Bachelor’s degree in a technical field (i.e. engineering) or related discipline with relevant experience in leadership/project management role.
Minimum of 8 years related working experience in Medical Device or Pharmaceutical industry.
Bilingual in Chinese a plus.
Experienced and strong leader who can facilitate cGMP programs.
Proficient in MS Office, Basic CAD drawing, ERP experience a plus.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive pay and an extensive benefits package including paid time off, medical, dental and vision benefits. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow within the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.