Endotronix
Document Control & Training Specialist
Endotronix, Naperville, Illinois, United States, 60564
WHO ARE WE?
Endotronix is a medical device company that aims to
transform the treatment of heart failure , a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. With our recent PMA approval from the FDA, we are preparing to grow our team - it's a great time to join Endotronix
WHAT YOU'LL DO
The
Document Control and Training Specialist
is responsible for overseeing the document control and training processes at Endotronix, in compliance with applicable Quality procedures. They have a strong understanding of Quality Management System (QMS) fundamentals and help to maintain and strengthen Endotronix's existing culture of quality. This individual is a subject matter expert on the document and training modules of the e-QMS software (Grand Avenue) and is confident in providing excellent technical support to users, troubleshooting issues, and recommending and implementing process improvements in the scope of their expertise.Manage the day-to-day requirements of the document control and training processes at Endotronix.Serve as administrator and/or coordinator of the document control and training modules of the e-QMS software ("Grand Avenue").Receive, scan, organize, and file paper and electronic documents in secure locations for quick retrieval.Process documents for revision and approval in Grand Avenue by reviewing for formatting, completeness, and compliance with regulations.Serve as the point of contact for the retrieval and distribution of controlled documents, as needed.Support other departments in the creation and maintenance of new training curricula/training plans per core function and Quality System requirements.Develop, maintain, and implement structured methodology for management/review of training plans and job descriptions.Assess the current and future needs of the organization and provide recommendations for the system.Perform on-going maintenance of the training system.Test/audit the quality management system to ensure its effectiveness for the user.Lead and/or assist with internal audits on an as-needed basis, including reporting and follow-up.Serve as a resource during external audits, such as those by the FDA or ISO registrar.Update procedures for compliance requirements, and/or to remediate identified gaps.Develop/promote company training communications, to promote employee training programs.Compile and analyze training and document control-related data and prepare reports/recommendations.Execute on all improvement efforts related to:Storage, retrieval, updating, and version control for documents in the QMS.Good Documentation Practices.Training effectiveness and alignment of training to job function responsibilities.Storage and retrieval of quality system records.Training compliance across the company - collaborating with other functionsServe as backup Supplier Module Coordinator in the e-QMS software when primary contact is unavailable.WHAT YOU BRING TO THE TABLE
The ideal Document Control and Training Specialist candidate has:
A four-year college degree, education, and/or training certification or equivalent experience.A minimum of 3 years of experience in the Quality discipline.Proficiency in interpreting training requirements in ISO 13485:2016 and FDA 21 CFR Part 820 or similar standards and regulations.The ability to clearly and confidently communicate information at multiple organizational levels (e.g., technician to management).Experience with quality systems including document control, training, CAPA, nonconformances, conformity to standards, records management, etc.The ability to effectively educate others on quality system requirements according to established procedures.The ability to work in a flexible, fast-paced, team environment.Excellent interpersonal and communication skills, with the ability to negotiate and influence others.Strong organizational skills with attention to detail.Excellent English written and verbal skills.The ability to independently manage their own time and projects.Demonstrated experience creating compelling training materials for a variety of audiences.Demonstrated experience creating reports, generating, interpreting, and presenting metrics.A strong working knowledge of Microsoft Office (Word, PowerPoint, Excel), Adobe Acrobat, and flow charting software.EDUCATION
Four-year college degree, education, and/or training certification or equivalent experience.WHO YOU ARE
Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customersSomeone with a bias for action and quick iteration as opposed to perfectionA quick learner, who is able to work independently, multitask, and drive your own projectsAn effective communicator and collatorator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights models and tools that provide easily interpretable and actionable resultsA team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the partsPassionate about digital healthcare and leveraging Data to deliver innovative solutions at scaleWHAT WE'RE LIKE
Willing to have the "direct and honest conversation". Not afraid to confront the facts (or be confronted) and develop a plan to move forward.Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.Entrepreneurial, flexible, yet results focused.High degree of intellectual curiosity, honesty, and capability.Low ego and humble in spirit in spite of your track record of outstanding performance.
LIFE AT ENDOTRONIX
Endotronix. is an equal opportunity employer. We are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status or disability.
Furthermore, we do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors. This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination and all other privileges, terms and conditions of employment.
This policy applies not only to recruitment and hiring practices, but also includes affirmative action in the area of placement, promotion, transfer, rate of pay and termination.
Endotronix is a medical device company that aims to
transform the treatment of heart failure , a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. With our recent PMA approval from the FDA, we are preparing to grow our team - it's a great time to join Endotronix
WHAT YOU'LL DO
The
Document Control and Training Specialist
is responsible for overseeing the document control and training processes at Endotronix, in compliance with applicable Quality procedures. They have a strong understanding of Quality Management System (QMS) fundamentals and help to maintain and strengthen Endotronix's existing culture of quality. This individual is a subject matter expert on the document and training modules of the e-QMS software (Grand Avenue) and is confident in providing excellent technical support to users, troubleshooting issues, and recommending and implementing process improvements in the scope of their expertise.Manage the day-to-day requirements of the document control and training processes at Endotronix.Serve as administrator and/or coordinator of the document control and training modules of the e-QMS software ("Grand Avenue").Receive, scan, organize, and file paper and electronic documents in secure locations for quick retrieval.Process documents for revision and approval in Grand Avenue by reviewing for formatting, completeness, and compliance with regulations.Serve as the point of contact for the retrieval and distribution of controlled documents, as needed.Support other departments in the creation and maintenance of new training curricula/training plans per core function and Quality System requirements.Develop, maintain, and implement structured methodology for management/review of training plans and job descriptions.Assess the current and future needs of the organization and provide recommendations for the system.Perform on-going maintenance of the training system.Test/audit the quality management system to ensure its effectiveness for the user.Lead and/or assist with internal audits on an as-needed basis, including reporting and follow-up.Serve as a resource during external audits, such as those by the FDA or ISO registrar.Update procedures for compliance requirements, and/or to remediate identified gaps.Develop/promote company training communications, to promote employee training programs.Compile and analyze training and document control-related data and prepare reports/recommendations.Execute on all improvement efforts related to:Storage, retrieval, updating, and version control for documents in the QMS.Good Documentation Practices.Training effectiveness and alignment of training to job function responsibilities.Storage and retrieval of quality system records.Training compliance across the company - collaborating with other functionsServe as backup Supplier Module Coordinator in the e-QMS software when primary contact is unavailable.WHAT YOU BRING TO THE TABLE
The ideal Document Control and Training Specialist candidate has:
A four-year college degree, education, and/or training certification or equivalent experience.A minimum of 3 years of experience in the Quality discipline.Proficiency in interpreting training requirements in ISO 13485:2016 and FDA 21 CFR Part 820 or similar standards and regulations.The ability to clearly and confidently communicate information at multiple organizational levels (e.g., technician to management).Experience with quality systems including document control, training, CAPA, nonconformances, conformity to standards, records management, etc.The ability to effectively educate others on quality system requirements according to established procedures.The ability to work in a flexible, fast-paced, team environment.Excellent interpersonal and communication skills, with the ability to negotiate and influence others.Strong organizational skills with attention to detail.Excellent English written and verbal skills.The ability to independently manage their own time and projects.Demonstrated experience creating compelling training materials for a variety of audiences.Demonstrated experience creating reports, generating, interpreting, and presenting metrics.A strong working knowledge of Microsoft Office (Word, PowerPoint, Excel), Adobe Acrobat, and flow charting software.EDUCATION
Four-year college degree, education, and/or training certification or equivalent experience.WHO YOU ARE
Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customersSomeone with a bias for action and quick iteration as opposed to perfectionA quick learner, who is able to work independently, multitask, and drive your own projectsAn effective communicator and collatorator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights models and tools that provide easily interpretable and actionable resultsA team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the partsPassionate about digital healthcare and leveraging Data to deliver innovative solutions at scaleWHAT WE'RE LIKE
Willing to have the "direct and honest conversation". Not afraid to confront the facts (or be confronted) and develop a plan to move forward.Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.Entrepreneurial, flexible, yet results focused.High degree of intellectual curiosity, honesty, and capability.Low ego and humble in spirit in spite of your track record of outstanding performance.
LIFE AT ENDOTRONIX
Endotronix. is an equal opportunity employer. We are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status or disability.
Furthermore, we do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors. This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination and all other privileges, terms and conditions of employment.
This policy applies not only to recruitment and hiring practices, but also includes affirmative action in the area of placement, promotion, transfer, rate of pay and termination.