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Supervisor, Document Control
4 months ago
About The Team:
Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together
The Document Control Supervisor provides leadership and establishes priorities for a team of document control professionals. Throughout the day, they collaborate with cross functional teams to establish priority processing for change requests, manage the off-site record storage, and ensure that the appropriate quality system training has been assigned to employees. This role blends regulatory compliance, electronic change management and training system administration, and team leadership to ensure operational excellence and adherence to company and industry standards.
A Day In The Life Of Our Document Control Supervisor
:
Oversee the document control change process from draft through approval, implementation and archive.
Develop, implement, and maintain document control procedures to ensure accuracy and compliance.
Define and report on the metrics related to change management process efficiency.
Collaborate with stakeholders to identify, define, and implement opportunities for improved change management and training Process Workflows.
Oversee the creation, review, approval, distribution, and archival of documents.
Reviews and approves administrative changes to controlled documents for Quality Assurance
Serve as the administrator for the document control and training modules of the eQMS.
Training of others staff members on document control, training, and record retention procedures.
Monitor system performance and troubleshoot issues to ensure uninterrupted functionality.
Coordinate off-site storage of physical records, ensuring proper organization and accessibility.
Implement retention schedules and oversee disposal of expired records in compliance with regulatory requirements.
Coordinates document requests and stages documents for presentation during regulatory inspections.
Collaborate with HR and department managers to develop training plans for new employees.
Coordinate training sessions and track completion of training requirements.
Facilitate training on revised procedures and ensure documentation is updated accordingly.
Monitor and provide reporting metrics related to on-time training performance.
Review and approve procedures, work instructions, and other governing documents pertaining to areas of responsibility.
Act as a Subject Matter Expert (SME) and provide guidance and training how to utilize the change management and training modules of the eQMS.
Maintain trained status for, and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
Strong leadership, communication, and cross-functional collaboration skills.
Lead and mentor a team of document control specialists.
Foster a positive and collaborative team environment that encourages innovation and continuous improvement.
Attract, retain, and develop top talent within the team, including conducting performance evaluations and providing feedback.
Other QMS activities not specified here and as assigned.
About You:
Requires undergraduate degree and 6+ years of work experience in the medical device industry, or equivalent work experience in lieu of degree.
Minimum of 2 years of supervisory experience
Strong organizational skills; ability to be proactive, multitask efficiently, complete tasks on time, and handle deadlines under pressure
Understanding of work processes and life cycle of documents
Experienced in Microsoft Office, Google Suite, and ePLM/eQMS systems.
Excellent verbal and written communication skills and interpersonal skills
Workplace Type: Onsite
Benefits & Perks (For Full Time Employees):
Competitive Salary
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days
Paid parental leave
In-office snacks and beverages
In-office lunch stipend
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
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