Senior Quality System Specialist/Document Control (Hybrid)
Location: Minneapolis, Minnesota
Type: Full Time
Preferred Education: 4 Year Degree
4 Year Degree
Internal Number: 610-20220726-77
Founded in 2001, CVRx is a leader in innovative technologies that address the unmet needs in cardiovascular diseases with safe and effective therapies. We have developed truly groundbreaking technology that is improving patient lives across the globe. CVRx is comprised of dedicated and talented industry leaders working together to make a mark within the medical device industry.
CVRx is entering an exciting phase as we launch Barostim – a transformative neuromodulation approach to treat heart failure in the US and globally. This position is an integral member of the small but growing Quality team that will be critical to our success – it is a great opportunity for a Senior Quality System Specialist to join us and have a high degree of responsibility and visibility within CVRx.
This position is responsible for assisting in designing, implementing and maintaining a quality / documentation control system. Working with teams across the company to develop and maintain documentation to support the quality system and comply with U.S. and international regulations. Maintaining and controlling distribution of quality systems documentation on-line. Providing quality support and solutions to internal and external customers to promote continuous process improvement. Establishing and measuring quality standards and communicate results to management.
Assist teams throughout the company to identify, document, and implement Quality Systems Documentation, including policies, processes, procedures, work instructions, and forms.
Oversee and maintain the Quality System document control system. Coordinate all activities related to processing change orders, including product, document, and manufacturer change orders. Oversee structure and processing of supplier records, corrective and preventive actions (CAPAs), complaints, issues, nonconforming material report (NMRs), calibration data, marketing materials, labeling, and CVRx website revisions.
Assist with identifying, documenting, and reporting key metrics for their processes.
Assist in complying with worldwide quality system regulations.
Maintain product structure, including consistent nomenclature for all assemblies, hardware, documentation, etc.
Participate with and direct 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, documenting findings and observations, and tracking and verifying actions to address assigned past findings and observations. Participation as a lead auditor includes planning, scheduling, and implementing internal audits.
Participate in external audits by Notified Bodies, FDA, and other regulators, as 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.
Assist with translation activities, including coordinating with the translation supplier, as required.
Perform miscellaneous duties as assigned by the head of Quality.
College degree or equivalent experience.
Experience with oversight of Quality System Documentation Control systems.
Minimum three years related experience in process or procedure writing, technical writing, or publications.
Background in quality systems and basic understanding of ISO 13485 and U.S. QSR 21 CFR 820.
Knowledge of software applications (such as Microsoft Word, Excel, PowerPoint, etc.)
Working knowledge of Agile software application is strongly preferred.
Basic knowledge of Integrity/Windchill software application.
Excellent communication, leadership, and organizational skills.
Experience with internal auditing.
Normal office conditions. In office is desirable but remote work is feasible.
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.
Our employees enjoy working at a company that truly cares about them, their careers, and overall wellbeing. We offer competitive salaries, great benefits, paid time off, and holidays. We are rapidly expanding and look forward to adding more talent to our team.
CVRx 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.
CVRx is focused on the development and commercialization of Barostim™, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.
CVRx® advances health for people everywhere, giving each patient a fuller life.
CVRx® pioneers unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx® a universal role model in healthcare.
Commitments are sacred: Honor relationships by doing what we say, when we say we’ll do i...t.
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Collaborate with Enjoyment: Achieve goals and celebrate as a team.
Determination overcomes Targets: Determine the pathway, overcome obstacles, accelerate, and successfully implement.
Embrace the Challenge of Change: Have an eye for identifying when change is needed, and the flexibility to chart a new course.