Senior QMS Specialist - Medical Devices
- provide Quality and Regulatory support to the manufacturing and R&D activities.
- be responsible to maintain the QMS systems, specifically the NC/CAPA, change control, and internal audit programs.
- be responsible for the employee training program and assist with the safety program.
- Execute and maintain the NC/CAPA system
- Maintain QMS system
- Provide support to the QMS activities within the company, specifically the Design Control process
- Act as liaison and work with R&D and manufacturing regarding quality and compliance issues
- Perform the internal audits and assist with management review
- Maintain the Training Program
- Write technical documents – procedures, protocols, reports, validations, etc.
- Document/Change control
- Materials Review Board
- Work on multiple, simultaneous projects, which require the ability to manage time flexibly and interact with a variety of people
- B.S degree in Life Sciences (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, etc.), Engineering or a technical field, M.S degree preferred
- Certification a big plus, such as RAC from RAPS
- Knowledge of and 5 years of experience with Quality Systems regulations including 21 CFR 820 and ISO 13485
- 1 year of experience with the execution of quality systems like CAPA, NCMR, deviations and document control
- 2 years of experience with QMS system and technical writing
- High level of experience and understanding of GMP/GLP system requirements
- Experience with medical device inspection and testing, bio-analytical knowledge for antibody testing/verification
- Strong regulatory compliance and technical background, statistical knowledge and analytical skills
- Excellent skills in organization, record keeping and oral and written communications
- Strong interpersonal skills and multi-cultural awareness, able to negotiate and build consensus and to develop effective relationships through collaboration
- Able to adapt to a fast-paced work environment and must have a strong work ethic to complete assignments with high quality under tight deadlines
- Bilingual in English and Mandarin a plus