Document Control and Training Manager

Calyxo, Inc.; Fort Erie; On-site; USD 110,000 - 140,000; Full time

Job summary

An innovative medical device company is seeking a detail-oriented professional to manage their Document Control System and Quality Records Program. This role involves ensuring compliance with regulatory standards, overseeing the effective functioning of the electronic Quality Management System (eQMS), and collaborating with various departments to enhance document transfer processes. Join a dynamic team dedicated to improving kidney stone treatment and enjoy a competitive salary, stock options, and comprehensive benefits in a diverse and inclusive environment. Your expertise will play a crucial role in shaping the future of healthcare solutions.

Benefits

Stock options

401(k)

Healthcare benefits

Paid vacation

Qualifications

• 5+ years of experience in Document Control and Quality Systems in medical devices.
• Knowledge of FDA QSR and ISO 13485 standards.

Responsibilities

• Manage Document Control System and Quality Records Program for compliance.
• Oversee eQMS system development and implementation.

Skills

Document Control

Quality Systems

FDA QSR

ISO 13485

Microsoft Office Suite

Project Management

Education

Bachelor's degree or equivalent practical experience

Tools

Prople PLM

Job description

Company Overview

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. Founded in 2016, our mission is to improve kidney stone treatment. Kidney stone disease is a common, painful condition that consumes significant healthcare resources annually. Our leadership team comprises executives and investors with a proven track record of commercializing innovative devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We seek high achievers eager to join a dynamic, diverse, and engaging team.

In This Role, You Will:

• Manage and improve the Document Control System and Quality Records Program to ensure compliance, effectiveness, and efficiency, supporting current and future business needs.
• Ensure the company's eQMS functions effectively to meet the needs of internal customers and aligns with company objectives.
• Oversee all aspects of the eQMS system, including development, validation, and implementation of new modules as the business grows.
• Lead impact assessments and software validations for Propel Software updates and changes.
• Maintain compliance of document control processes with regulatory requirements and ensure department procedures are up-to-date.
• Guarantee the ongoing effectiveness of the eQMS related to ECOs/DCOs, document management, and training processes.
• Securely manage electronic and hard copy controlled documents, ensuring data recovery capabilities.
• Collaborate with Operations, R&D, and Supplier Quality to establish document transfer processes with suppliers and contract manufacturers.
• Monitor and report on Document Control metrics to improve system performance.
• Oversee training programs to ensure compliance and effectiveness, including instructor-led sessions.
• Manage the External Standards Program, ensuring standards are current and accessible, and perform gap assessments for revised standards.
• Establish and maintain SOPs, Work Instructions, and Forms related to document control and training.
• Train and support personnel on best practices and workflows in document control and training systems.
• Participate in Management Review meetings, preparing and presenting data on QMS performance.
• Coordinate with government agencies and external consultants for audits and inspections, addressing findings promptly.
• Develop and report on quality objectives, metrics, and goals at both corporate and departmental levels.

Reporting Line

Reports to: Sr Director, Quality

Requirements:

• Bachelor's degree or equivalent practical experience preferred.
• At least 5 years of experience in Document Control and/or Quality Systems within the medical device industry, including experience with electronic QMS and Prople PLM is preferred.
• Location: Pleasanton, CA.
• Travel up to 10%.
• Knowledge of FDA QSR, ISO 13485, and related standards.
• Strong organizational skills with the ability to manage multiple projects with attention to detail.
• Proficiency in Microsoft Office Suite.
• Physical ability to lift 10 pounds and sit for extended periods.
• Compliance with vaccination regulations as applicable.

What We Offer:

Join Calyxo's knowledgeable and high-achieving team in a diverse environment that fosters growth and learning. We offer:

• Competitive salary: $110,000 - $140,000
• Stock options for ownership stake
• Comprehensive benefits including 401(k), healthcare, and paid vacation

Our Commitment to Diversity and Inclusion

Calyxo values diversity and is committed to creating an inclusive environment. We are an equal opportunity employer, considering all applicants regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other protected characteristics. Legal authorization to work in the U.S. is required, and all hires must verify their eligibility upon employment.