Document Control Clerk
A medical device manufacturing company in Sunnyvale, CA is seeking a documentation control clerk to assist the quality systems team. This position is responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485, the IVD directive and CMDR/CAS. Specifically, functions including the document control system and administrative support are the primary responsibilities of this position. Duties for this position support production, batch record issuance, retrieval of quality records, the preparation of manifest for off-site storage of hard copy quality records and scanning of laboratory notebooks.
- Support of document control system (using Agile PLM software application).
- Support of the manual document control system filling copy requests, document issuance, and filing, and resolution of issues as necessary.
- Review of product documentation and records, as needed.
- Control and organization of paper records, both active on site and off site archives.
- Generate or update standard operating procedures to define and improve quality system functions.
- Revise existing documentation and processes to support continuous improvement.
- Interfacing with company personnel regarding documentation requirements.
- Track and update periodic QA/ Document Control metrics.
- Support quality audits (internal and external).
Minimum of one year experience, quality system or related discipline, with practical experience in a regulated manufacturing environment.
Computer skills essential, e.g., word, excel, access, electronic documentation
Excellent verbal and written communication skills are a must; in-group or one-on-one settings.
Experience teaching/mentoring others to support continuous improvement.
Ability to identify and correct of gaps within the system.
Ability to interface well with people of varied backgrounds is essential.
Understanding of general mathematical principles and calculations, at college entry level.
Experience in compiling data to support metrics analyzing current processes
Experience with an electronic document management system Agile is a plus.
Experience in DNA diagnostics, instrument/reagent manufacturing, or medical devices is a plus.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.