Director, Quality and Compliance

CVRx • Brooklyn Park, MN

2d • Hybrid

About The Position

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. This role is hybrid with 4 days a week in office at our Brooklyn Park, MN headquarters. At CVRx, the Director, Quality and Compliance provides leadership in the development, implementation, and maintenance of CVRx’s quality system and associated quality engineering activities. Independently defines and specifies the implementation of standards, quality system training, quality programs, and the quality auditing of CVRx’s products, processes, and services. This Quality and Compliance leader will ensure management is made aware through effective and timely communication of any business or compliance risks with plans to minimize the potential exposure. Through leadership, knowledge, and communication, the Director of Quality and Compliance is a driving force in the company’s pursuit of excellence in all aspects of our company.

Requirements

• 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

Nice To Haves

• MBA
• Experience working with electrical implantable medical devices
• Basic knowledge of eQMS and Windchill software applications
• Start-up or growth-stage company experience is preferred

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director