Document Control Specialist
San Jose, CA
A medical device manufacturing start-up in San Jose, CA is looking for a Document Control Specialist with excellent skills with Agile.
- Ensure efficient processing of change orders and documents in the Agile PLM.
- Oversee the use of the Agile PLM and QMS systems for document control and training ensuring that it is appropriately maintained, supported and effectively used.
- Ensure that users are trained in the electronic PLM and QMS systems and that the organization is making valuable use of its capabilities.
- Provide regular updates to the management, on Systems and Processes; escalate unresolved issues in a timely manner.
- Provide training and guidance in the areas of responsibility for internal customers.
- Manage controlled document and record archiving area and associated electronic systems.
- Maintain Quality Metrics & KPIs for document control and employee training activities and implement process improvements.
- Drive, track and maintain employee Quality training.
- Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, and all other international regulatory requirements with which the company complies.
- Recognize challenges and escalate in a timely manner to resolve issues.
- Ensure adherence to Company Quality policy.
- Perform other duties as assigned.
Bachelor’s Degree or High School Diploma with relevant work experience.
1-2 years of experience working in a regulated industry or similar manufacturing and engineering environments preferred.
Experience with Agile Product Lifecycle Management (PLM).
Microsoft Office Suite.
Basic knowledge of Good Documentation Practices (GDP).
Highly organized and detail oriented with strong follow-up skills to manage large volumes of documentation. Ability to understand priorities.
Excellent written and verbal communication skills.
Accuracy is required in performing all functions of this position.
Must demonstrate proficiency in computer skills and Microsoft Word, Excel and Visio, and Adobe Acrobat..
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.