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Head of Quality Systems
2 months ago
As the Senior Director of Quality Assurance & Quality Systems at CVRx, you will play a pivotal role in steering the establishment, execution, and ongoing enhancement of quality assurance frameworks and initiatives. Your responsibilities will include defining and outlining the implementation of standards, methodologies, processes, and quality training to uphold excellence across all facets of our organization.
Core Responsibilities:
- Act as the management representative for the quality system.
- Supervise quality systems encompassing change control, vendor qualification, records management, equipment and process validation, internal and external audits, among others.
- Guide the formulation and revision of corporate quality policies and auditing practices.
- Oversee ISO 13485 and MDSAP certification to ensure adherence to compliance standards.
- Support organizations in the creation and execution of quality systems that align with regulatory mandates.
- Establish essential quality assurance metrics and deliver management reports.
- Guarantee compliance with global regulatory standards across various domains.
- Execute additional tasks as assigned by CVRx management.
Qualifications:
- Bachelor's degree in a relevant discipline.
- A minimum of 15 years of experience in quality assurance, with at least 5 years in the medical device sector.
- Familiarity with QSR/MDR/GMP/ISO and international standards.
- An MBA degree is preferred.
- Exceptional communication, leadership, and organizational capabilities.
Work Environment:
- Standard office conditions.
- Travel may be required up to 10% of the time, including some international travel.
- Full vaccination against certain diseases may be required.
Employee Benefits:
- Health & Dental Insurance options covered by the company.
- 401(k) plan with company matching.
- Employee stock purchase plan and stock option grants.
- 12 paid holidays annually plus PTO.
- Paid parental leave.
- Company-sponsored life insurance and disability coverage.
- Opportunities for unlimited professional growth.
- Access to training and development programs.
- Flexible work schedules.
If you are a dedicated professional eager to make a significant impact in the field of cardiovascular health, consider joining CVRx and contributing to our innovative technological advancements.
