Document Control and Training Manager - Pleasanton, CA

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

In This Role, You Will:

• Manage and maintain the Document Control System and Quality Records Program with an emphasis on continuous improvement, systems effectiveness, efficiency and compliance to meet regulatory requirements, and current and future business needs.
• Ensure the company’s eQMS operates effectively and efficiently to meet the needs of internal customers, business objectivies/needs and Company Quality Ojectivies.
• Responsible for managing and maintaining all aspects of the eQMS system.
• Partner with cross-functional teams to develop, validate, and implement additional eQMS modules that are aligned with the Company's growing business needs.
• Responsible for leading and executing impact assessments and S/W validations for Propel Software release/upgrades/changes.
• Ensure document control processes and procedures are compliant with regulations and that department procedures are current and adequate to meet applicable regulations.
• Ensure the on-going effectiveness and compliance of the eQMS as it relates to ECOs/DCOs, document management, and training processes
• Manage electronic files and hard copy files of controlled documents in a secure manner to prevent unauthorized changes and coordinate back-ups of electronic files to ensure recovery in the event of lost data.
• Collaborate with with Ops, R&D and Supplier Quality as applicable to ensure processes for released document transfer are established with Suppliers / Contract Manufacturers as appropriate/necessary.
• Measure, monitor, and report on Document Control metrics to ensure system effectiveness, efficiency, and implementation of updates/changes as necessary.
• Monitor the Company's eQMS to ensure that training and retraining on all required procedures and latest revisions are performed, including instructor lead training sessions.
• Measure, monitor and report on Training metrics to ensure system effectiveness and efficiency, and implement updates/changes as necessary to meet changing business needs.
• Manage and maintain the Training Program with an emphasis on continuous improvement and system effectiveness and efficiency to meet regulatory requirements, and current and future business needs.
• Manage the External Standards Program. Ensure external standards are maintained, current, accessible, and available for use.
• Partner with service providers on external document change notifications and the purchasing of new and revised standards as applicable.  Ensure gap assessments are performed for applicable revised/updated externals standards by appropriate Company personnel.
• Establish and maintain Standard Operating Procedures (SOPs), Work Instructions, and Forms related to areas of document control and training.
• Advise, train, and support Company personnel in best practices, processes and approaches concerning areas of responsibility, including Document Control and Training system requirements and workflows.
• Participate in Management Review meetings and assist in gathering, preparing, analyzing and presenting data to Executive Management on the performance of the Quality Management System for areas of responsibilities.
• Interact and interface with various government agencies, private companies, and consultant (such as CA FDB, US FDA, Notified Bodies, external consultants), related to quality system audits/inspections and assist in timely responses to any findings.
• Develop, establish, monitor, and report on both corporate and departmental quality objectives, metrics, and goals.

Who You Will Report To:

• Sr Director, Quality

Requirements:

• Education: BS or BA degree or related practical experience preferred.
• Minimum 5 years of experience in Document Control and/or Quality Systems in the medical device industry. Experience with using, administering, validating, implementing, and maintaining electronic Quality Management Systems (eQMS). Experience with Prople PLM is preferred.
• Work location: Pleasanton, CA.
• Travel: Ability to travel up to 10%.
• Full time employment
• Knowledge of national and international quality systems requirements (e.g. FDA QSR, ISO 13485, and related EN/ISO standards).
• Excellent level of organizational skills and ability to work and drive multiple projects at the same time with high level of attention to detail.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook)
• Must be able to lift 10 pounds, sit for up to 8 hours/day.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive base salary of $110,000- $140,000
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. 
 
Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.