Job details

Quality Systems Specialist

Why work for CVRx?

CVRx pioneers' unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.

A day in the life:

Responsible for helping maintain the quality / documentation control system. Work with teams across the company to develop and maintain documentation to support the quality system and comply with U.S. and international regulations. Maintain and control distribution of quality systems documentation on-line. Provide quality support and solutions to internal and external customers to promote continuous process improvement. Participate as a key member of the auditing staff.

Key Duties and Responsibilities:

Assist teams throughout the company to identify, document, and implement Quality Systems Documentation, including policies, processes, procedures, work instructions, and forms.
Help maintain the Quality System document control system including coordinating activities related to processing change orders, including product, document, and manufacturer change orders. Help oversee processing of supplier records, corrective and preventive actions (CAPAs), issues, calibration data, marketing materials, labeling. Maintain product structure, including consistent nomenclature for all assemblies, hardware, documentation, etc.
Assist in complying with worldwide quality system regulations.
Participate with functional organizations in meeting customer satisfaction goals and promote continuous process improvement.
Participate in the internal quality audit system by being an auditor and auditee. This includes auditing of assigned policies and procedures, and documenting findings and observations.
Participate in external audits by Notified Bodies, FDA, and other regulators, when required.
Assist with capturing results related to the calibration of measurement equipment: calibration status, internal or external calibration, tracking of calibration results, and documentation of recalibration timing, as required.
Maintaining Quality System training documentation and administration tasks associated with Quality System training
Perform miscellaneous duties as assigned by the head of Quality.

What we expect from you:

College degree or equivalent experience.
0-3 years experience with management of Quality System Documentation Control systems.
Knowledge of software applications (such as Microsoft Word, Excel, PowerPoint, etc.).

What we would like to see:

Working knowledge of Agile software application is strongly preferred.
Basic knowledge of Integrity/Windchill sofware application.
Basic knowledge of Enterprise Resource Planning (ERP) software applications.
Background in quality systems and strong understanding of ISO 13485,U.S. QSR 21 CFR 820, and EU MDR is strongly preferred.
Excellent communication and organizational skills.

What we offer:

We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun. We also offer a competitive benefits package, details listed below:

Health & Dental Insurance options with generous Company contributions
Company contributions to an HSA with a high deductible insurance plan.
401(k) with company match.
Employee stock purchase plan & stock option grants.
12 company-paid holidays per year + PTO.
Paid time off for new parents.
Company-paid life insurance & disability.
Unlimited growth opportunities.
Training & learning opportunities.
Flexible Schedules.

Working Conditions

Hybrid of normal office conditions and remote work.
Must be fully vaccinated per CDC guidance against the COVID-19 virus and willing to comply with pre-employment screening, including but not limited to reference verification and background check.

EEO statement

CVRx, Inc. provides equal employment opportunities to all employees and 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.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great things and a have a background in medical devices, healthcare or a related field, we want to hear from you!

If you need assistance or an accommodation due to a disability, you may contact us at humanresources@cvrx.com

This requisition will be open until filled.

What You Should Know About Quality Systems Specialist, CVRx

At CVRx, we're at the forefront of transforming healthcare with our unique therapies designed to harmonize the body's natural systems. As a Quality Systems Specialist, you will play a pivotal role in ensuring our quality and documentation control systems are top-notch. Imagine diving into a day's work where you're collaborating with various teams across the company to develop and maintain essential documentation, keeping us compliant with both U.S. and international regulations. Your responsibilities will include managing the quality system document control, processing change orders, and overseeing supplier records. You'll also be integral in enhancing our quality audit processes as both an auditor and auditee. What gets us excited is your ability to provide quality support and solutions, driving continuous improvements within our processes. If you have a passion for quality systems and appreciation for cutting-edge medical technologies, you belong here with us at CVRx! Why settle for the ordinary when you can contribute to something extraordinary while enjoying a culture that values teamwork, creativity, and fun? Join us in our mission, and experience the joy of making a difference in people's lives while developing your career in a supportive and dynamic environment.

Frequently Asked Questions (FAQs) for Quality Systems Specialist Role at CVRx

What are the main responsibilities of a Quality Systems Specialist at CVRx?

As a Quality Systems Specialist at CVRx, your main responsibilities will include maintaining and improving our quality documentation control system, collaborating with teams to develop crucial documentation like policies and procedures, and overseeing the processing of change orders. You'll be expected to participate in internal and external audits and assist in capturing calibration data for measurement equipment. Your role is vital in ensuring compliance with worldwide quality standards, making a significant impact on enhancing our processes.