Senior Quality Assurance Specialist

3 days ago


Brooklyn Park, Minnesota, United States CVRx Full time

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.

">Job Summary

The Senior Quality Assurance Specialist will assist teams across the company to develop and maintain documentation to support the quality system and comply with U.S. and international regulations. The successful candidate will have 0-3 years experience with management of Quality System Documentation Control systems.

About This Role

This is an excellent opportunity for a motivated individual with a passion for cutting-edge medical technologies to join our team and contribute to our mission to help others live better lives. As a key member of our auditing staff, you will be responsible for helping maintain the quality / documentation control system and participating in internal quality audits.

Key Responsibilities
  • Assist teams throughout the company to identify, document, and implement Quality Systems Documentation, including policies, processes, procedures, work instructions, and forms.
  • Maintain the Quality System document control system, including coordinating activities related to processing change orders, including product, document, and manufacturer change orders.
  • Oversee the processing of supplier records, corrective and preventive actions (CAPAs), issues, calibration data, marketing materials, labeling.
  • Assist in complying with worldwide quality system regulations.
  • Participate with functional organizations in meeting customer satisfaction goals and promote continuous process improvement.
  • Perform miscellaneous duties as assigned by the head of Quality.
Requirements
  • College degree or equivalent experience.
  • 0-3 years experience with management of Quality System Documentation Control systems.
  • Knowledge of software applications (such as Microsoft Word, Excel, PowerPoint, etc.).
Salary Information

The estimated salary range for this position is between $70,000 - $90,000 per year, depending on experience.

We offer a competitive benefits package, which includes:

  • Health & Dental Insurance options with generous Company contributions
  • Company contributions to an HSA with a high deductible insurance 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.


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