LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads) on and off LinkedIn. Learn more in our Cookie Policy.
Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings.
Provides leadership in the development, implementation, and maintenance of CVRx's quality assurance systems and activities. Defines and specifies the implementation of standards, methods, processes, quality training, quality programs and the quality auditing of the CVRx's products, processes, and services. Through leadership, knowledge, and communication, the Senior Director of Quality Assurance & Quality Systems is a driving force in the company's pursuit of excellence in all aspects of our company.
Key Duties and Responsibilities{{:}}
Serve as the management representative to the quality system
Oversee quality systems to include change control, vendor qualification, records management, equipment and process validation, training and competency program and documentation, internal and external audits, standard operating standards (SOPs), process improvement, change control, and data review support
Facilitate the development and update of corporate quality policies and auditing practices as well as authorize their implementation
Manage the successful ISO 13485 and MDSAP certification and ensure the certification remains intact; including U.S. QSR 21 CFR 820 requirements and other country requirements as we enter into those markets
Assist organizations throughout the company to identify, document, and implement Quality Systems, including policies, processes, procedures, work instructions, and forms that ensure compliance to U.S. QSR 21 CFR 820, ISO 13485, EU MDR, and other worldwide regulatory requirements where devices are being marketed
Assist these organizations in the development and updates of departmental performance scorecards.
Schedule and lead regular management reviews per SOP requirements
Coordinate, collaborate, and communicate both internally and with our customers and suppliers to resolve problems/complaints and execute projects in a timely and effective manner
Develop key quality assurance metrics and provide routine management reporting and coordinated corrective and preventive action (CAPA) plans to address areas of deficiencies
Ensure training, as related to quality systems, procedures, and operator certification is effective and completed
Ensure compliance with worldwide regulatory standards in the areas of quality systems, risk management, medical device software development, wireless coexistence, usability, and cybersecurity
Perform miscellaneous duties as assigned by the CVRx management
Requirements
Required{{:}}
College degree in engineering, science, medicine or equivalent
Completion of a Quality System Audit Program or experience in Quality System auditing
Minimum 15 years' experience and in-depth background in quality assurance and/or quality systems, at least 5 years of which are in medical devices
Experience with QSR/MDR/GMP/ISO and applicable international standards and regulations as required by specific country markets
Knowledge of medical terminology
Preferred{{:}}
MBA degree
Local candidates or those willing to relocate strongly preferred
Excellent communication, leadership, and organizational skills
Experience working with electrical implantable medical devices strongly preferred
Basic knowledge of Agile and Windchill software applications
Experience working with Class III active implantable medical devices strongly preferred
Working Conditions{{:}}
Normal office conditions
Travel up to 10% of time including some international travel
May be required to be fully vaccinated against the COVID-19 virus and other diseases
Benefits
Company Paid Health & Dental Insurance options
Company contributions to an HSA if enrolled in a high deductible 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
This role is perfect for a highly skilled professional who thrives in a fast-paced, innovative environment and is passionate about making a significant impact in the field of cardiovascular health. Join us at CVRx and be at the forefront of transforming patient care through cutting-edge technology.
Seniority level
Executive
Employment type
Full-time
Job function
Quality Assurance
Industries
Technology, Information and Internet
Referrals increase your chances of interviewing at CVRx | Barostim by 2x