Director, Quality and Compliance

CVRx | Barostim

Director of Quality and Compliance overseeing the quality system and regulatory compliance for CVRx. Ensuring excellence in product development and management reporting for a medical device company.

Posted 7/6/2026full-timeBrooklyn Park • Minnesota • 🇺🇸 United StatesLead💰 $190,000 - $225,000 per yearWebsite

About the role

Key responsibilities & impact

Oversee aspects of the quality system including, but not limited to, change control, supplier quality, records management, equipment and process validation, training and competency program and documentation, internal and external audits, risk management, CAPA, data review, and management review.
Facilitate the development and update of corporate quality objectives.
Manage and coordinate with Regulatory for the successful maintenance of ISO 13485 and MDSAP certification including other country requirements as necessary.
Assist departments throughout the company to identify, document, and implement quality system procedures, including work instructions and forms that ensure compliance to worldwide regulatory requirements (as applicable), as well as guidance documents, standards and common specifications where devices are being marketed. Schedule and lead regular management reviews per procedural requirements.
Proactively coordinate, collaborate, and communicate with management and teams internally and with our customers and suppliers to resolve problems/complaints and execute projects in a timely and effective manner.
Communicate key quality scorecard metrics and provide routine management reporting and coordinated corrective and preventive action (CAPA) plans to address areas of deficiencies.
For significant product issues, coordinate the assessment of the issue, Health Hazard Evaluation, field action, field safety notice, and/or recall efforts, as appropriate.
Ensure training, as related to quality systems, procedures, and operator certification is effective and completed.
Ensure organizational capability to support ongoing product development and sustaining engineering programs along with manufacturing support for incoming inspection, product quality, and non-conforming material analysis.
Maintain a culture of high attention to quality in all aspects of product development and manufacturing.
Perform miscellaneous duties as assigned by management.

Requirements

What you’ll need

College degree in engineering, science, medicine or equivalent
History of completing Quality System Audit Programs and/or experience in Quality System auditing
10-15 years of experience and in-depth background in quality systems at least 5-8 years of which are in medical devices
In depth experience with QMSR/GMP/ISO and applicable international standards and regulations as required by specific country market requirements experience
Solid grasp of medical terminology
Excellent communication, leadership, and organizational skills
Ability to adapt and change as needed in a growth-stage company environment
Onsite presence working at our Brooklyn Park, MN headquarters at least 4 days per week is required

Benefits

Comp & perks

Competitive Health & Dental Insurance options with generous Company contributions
Company contributions to an HSA with a high deductible insurance plan selection
401(k) with a company match
Employee stock purchase plan (ESPP) & stock option grants
12 company-paid holidays per year in addition to a generous Flex PTO plan
Generous paid time off for new parents
Company-paid life insurance & disability options
Unlimited growth opportunities in a growing company
Endless training & learning opportunities
Flexible Schedule

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality System Audit ProgramsChange ControlSupplier Quality ManagementProcess ValidationRisk ManagementData ReviewRecords ManagementTraining and Competency ProgramInternal and External AuditsNon-Conforming Material Analysis

Soft Skills

Excellent CommunicationLeadership SkillsOrganizational SkillsAdaptabilityCollaboration