Neptune Medical is a venture backed medical device company based in Silicon Valley. We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technology. Pathfinder® is our first FDA-cleared commercial device incorporating this novel technology. This advanced endoscopy device is being used at a growing list of leading U.S. hospitals and academic medical centers. Now, the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.
TITLE: Senior Document Control Specialist
POSITION SUMMARY:
The Senior Document Control Specialist plays a critical role in ensuring the integrity, accuracy, and compliance of documentation processes within the medical device industry. This position is responsible for overseeing the document change control and training processes, and administrating the change process at Neptune Medical to ensure it meets regulatory and internal requirements. This position involves managing document workflows, maintaining quality system records, and supporting regulatory compliance efforts throughout all stages of product development, production, and market access. Document Control also creates and maintains Quality Management System profiles, facilitates periodic reviews for training plans and Quality documents, and supports QA during audits.
The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.
ROLES AND RESPONSIBILITIES:
- Review, route, and release change orders for compliance with Neptune Medical requirements.
- Ensure retention and retrieval of official documents and records.
- Assign new document and part numbers.
- Monitor and respond to emails in Document Control email box.
- Provide training and feedback to change order initiators, owners, and approvers.
- Administer the training process to ensure timely and compliant training.
- Ensure training plans are established for every employee at Neptune Medical.
- Update/assign training plans in eQMS.
- Train new hires on eQMS software and training program
- Generate reports on status of Change Orders.
- Perform analysis for Quality metrics, Management Review, etc.
- Represent areas of responsibility in internal and external quality audits.
- Participate in Document Control improvement initiatives, including updating Standard Operating Procedures (SOPs), Work Instructions (WIs), forms, and templates.
- Works in accordance with quality system procedures.
REQUIRED QUALIFICATIONS:
- AA/AS degree, 2+ years of experience, or a minimum of 4 years, in Document Control in a regulated industry.
- Experience using an electronic quality management system, e.g., Arena, EtQ. Experience using Propel is preferred.
- Understanding of 21CFR820 and ISO 13485 quality system requirements.
- Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
- Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
- Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint) and PDF software.
- Be results-oriented with appropriate urgency.
- Good organizational and oral and written communication skills.
- Willingness to work in a startup environment and adapt to changing needs and priorities.
- Eagerness to learn new things.
Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station
Our job titles may span more than one career level. The starting base salary for this role is between $117,000 and $135,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.
Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Top Skills
What We Do
Neptune Medical is a venture capital funded medical device start-up, located in the Silicon Valley town of Burlingame. We develop, manufacture, and commercialize high-volume, high clinical utility medical devices initially commercialized for gastroenterology, see our website below. Our patent-pending technology is foundational and will have a broad impact across multiple additional clinical areas, including including GI, cardiovascular, pulmonary, and neuro. Our Triton Medical Robotics division is developing flexible robotic systems that address enormous unmet needs across multiple major medical indications.
Our products incorporate unique Dynamic Rigidization™ technology that instantly toggles thin-walled tubes- such as overtubes, catheters or cannulae - between flexible and rigid states. This novel technology creates unprecedented opportunities for significantly enhanced access and control deep within the body.
Neptune Medical currently has ~50 full time employees across all divisions, including a core team of serially successful medical device entrepreneurs. The company has raised over $30M in capital from a diversified investor base, including venture capital, private equity, and industry insider and clinician angel investors.
