Documentation Coordinator\Document Processor(Product Release)

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Documentation Coordinator\Document Processor(Product Release).

Job Description:

Job Title: Documentation Coordinator\Document Processor(Product Release)

Job Type: Contract

Job Location: Sunnyvale, CA

Work Schedule: On-site

Pay Rate: $41 Based on experience

Description:

• The Senior Product Release (PR) Specialist is responsible for reviewing device history records (DHRs) for accuracy and completeness, certifying compliance to product specification and traceability requirements, and ensuring that any deviations from the manufacturing process were properly recorded and authorized by members of the appropriate departments.
• The Senior Product Release (PR) Specialist receives guidance on workload prioritization from the team lead/supervisor but is ultimately responsible for organizing and executing their projects and daily standard workload in a manner which meets the schedules of the operational teams whom they support.
• The Senior Product Release Specialist will also support by performing required non-value activities (e.g., training, presentations, data pull requests) that in turn allow team members to directly perform their assigned duties.

Essential Job Duties:

• Reviews and approves manufacturing Device History Records for all assembly levels, ensuring compliance with device master records and other Quality System requirements.
• Releases ISI products, including Instruments and Accessories for distribution according to the established procedures.
• Reviews and approves manufacturing Device History Records for all assembly levels, ensuring compliance with device master records and other Quality System requirements.
• Releases ISI products, including Instruments and Accessories for distribution according to the stablished procedures.
• Reviews and approves shipments of Single Use Devices to the sterilization process with the sterilizer contractor.
• Reviews, approves, and releases sterile products from Client or from a Contract Manufacturer.
• Documents non-conformances through the corresponding quality notification (NCR, VR, DN) via SAP.
• Works collaboratively with internal and external customers to resolve non-conformances in a timely manner.
• Escalates areas of concern to the Quality Assurance department and direct management.
• Performs all work according to Quality standards as set by the Quality Assurance department and direct management.
• Performs all work according to production, planning and logistics schedule, including working overtime as required.
• Escalating to the Quality Assurance department and direct management all Quality issues that could impact patient safety, surgical efficacy or traceability.
• Compliance with company department and standard operation procedures.
• Supports internal and external audits as required.
• Solve concerns about the procedures of his/her colleagues and members of other departments.
• Coordinates transfers of non-conforming material between plants.
• Provides support and guidance to his colleagues and Engineers during PPQ’s.
• Conduct current and new employee training.
• Lead improvement projects on the department.
• Ensuring successful, on-time completion of department projects; communication constraints to direct management when successful project completion is a risk.
• Publishes Quality and operational metrics to direct management.
• Be a key member on the resolution of problems related to documentation discrepancies that can have impact on the release of material.
• Provide regular sessions and refresher courses to existing team members to reinforce their understanding of our QMS and address any updates or changes to quality processes and requirements.
• Perform/support data pull requests as needed by the Supervisor/Lead.

Required Skills and Experience:

• Ability to read English, read and comprehend instructions, write short correspondences and memos, complete quality documentation in English, effectively present information in one on one and small group situations involving employees, supervisors, or engineers.
• Excellent verbal and written communication
• Demonstrated ability to be a quick learner and understand complex products and processes.
• Good Judgment: Strong ability to draw correlations to prior experience and identify precedent in ambiguous circumstances. Demonstrated track record of making good decisions.
• Ethical & Independent: Demonstrates recognition of the criticality of the job function and strives to conduct themselves in a manner which does not invite doubt about their ability to consistently execute process. Does not cut corners or bow to external pressure to compromise on requirements.
• Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions and when dealing with others.
• Initiative & Follow-through: Seeks opportunities to improve departmental process and expand personal contributions. Can be relied upon to complete commitments without excessive follow-up.
• Team-Oriented: Approaches their work selflessly and without ego, making an honest effort to manage their own assigned workload, communicating openly and in a timely manner when deliverables are at risk, and actively seeking opportunities to ask “How can I help?” Freely shares information and makes it a priority to mentor their peers when the opportunity presents itself.
• Presenting Skills: Proficient in delivering engaging and informative presentations to diverse audiences, including direct team members, engineering and cross functional teams. Ability to articulate complex ideas clearly and effectively.
• Training Expertise: Conduct training sessions, workshops and demonstrations to educate new and existing (PR) Product Release Specialist, Engineers and Operations personnel to QMS documents.
• Demonstrated ability to work independently and with minimal supervision, multi-task, and handle tasks with competing priorities effectively.
• Very strong computer skills and experience with Windows operating system and Microsoft Office.
• Ability to travel domestically and internationally.
• Availability to work on different Shifts as needed.
• Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820.
• Exceptional analytical, problem-solving, and root-cause analysis skills

Required Education and Training:

• Minimum 2 years of relevant experience as Product Release Specialist or Associate
• Highly proficient with Agile/ACCS and SAP

Working Conditions:

• Role is fulltime on-site.
• Must be available to manufacturing teams and for specialized roles.
• Must be able to walk long distances to validate release forms.
• OT will be required as needed per business need or per Supervisor/Manager discretion.
• Must be available to travel as needed 5-10%

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

Interested in Applying?

Please apply with your most current resume. Feel free to contact Raghav Pradhan (raghav@maxonic.com/(408) 400-2297) for more details.