Document Control Specialist (Hybrid - Sunnyvale)

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Document Control Specialist on a contract basis to support our customer's business needs. This role will be responsible for assisting the Document Control Lead and Manager in maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products and meet regulations and established requirements.

The candidate in this role will also ensure that product and product-related documents are processed through the Agile database in compliance with established procedures, Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Deviations, and Engineering Change Requests (ECRs). This role requires sedentary and repetitive working conditions.

What You’ll Do:

• Process documentation changes in Agile: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating, and processing changes accurately and in a timely manner while ensuring that they meet the department's goals and objectives
• Audit changes for accuracy and completion
• Review changes to ensure that the language used in the change is adequate and in compliance
• Ensure that changes are in a closed loop and all discrepancies (if any) are addressed and closed before the change is released
• Provide clear and accurate communication to internal customers
• Clearly communicate both verbally and in writing, with Originators when discrepancies are found
• Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies
• Provide Agile and change procedure training support as needed to co-workers within and outside Document Control
• Promptly respond to questions and issues raised by Originators and Approvers
• Work with ECO Coordinator to select changes for CCB meetings based on production impact
• Represent Document Control at CCB meetings
• Work with ECO Coordinator and Originators in following up, analyzing, and helping to resolve open ECO/MCO issues
• Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals
• Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals
• Provide change control training (processes and system) to users
• Maintain change control training materials up to date
• Create and maintain change control metrics and reports

Must Haves:

• 5+ years of experience working in Document Control in a Regulatory or Quality organization with a minimum of 3 years at a medical device company
• Experience processing changes using an electronic documentation system
• Proficient in using Word and Excel applications, and the Windows operating system
• Experience using Agile
• Must be able to work effectively in a fast-paced, team-oriented environment
• Ability to work independently with minimal supervision
• Demonstrated ability with database applications
• Demonstrated cross-functional teamwork skills
• Self-starting, detail-oriented, and ability to focus on the task at hand
• Ability to work independently with multiple departments to resolve Document Control issues
• Well-developed English written and verbal communication skills
• Familiarity with Design History requirements and documents
• Experience with and, clear understanding of the Quality System Regulations and ISO 13485 requirements

Education:

• Bachelor’s degree preferred
• Certification/Training in Product Lifecycle Management (PLM) Processes and Systems, Change Control Management, Quality System Regulations, and ISO 13485 2016 preferred

Hours & Location:

• M-F, 40 hours/week. This role will be on-site at our customer's Sunnyvale, CA office 3x/week.

All applicants applying for U.S. job openings must be legally authorized to work in the United States and are required to have US residency at the time of application.

Perks are available through our 3rd Party Employer of Record (Available upon completion of the waiting period for eligible engagements)

Health Benefits: Medical, Dental, Vision, Life (including spouse & child), 401k, STD/LTD, AD&D, and Commuter Benefits program.

The salary range for this position is: $38.87 - $48.87 per hour