QA RA Manager

Quality Assurance/Regulatory Affairs (QA/RA) Manager

INTRODUCTION

Founded in 2003, CS Medical LLC is a leader in developing, manufacturing, and marketing medical devices that are designed to provide high-level disinfection of ultrasound TEE probes. Our products are engineered and developed with one single objective in mind: to minimize the potential of patient exposure to improperly reprocessed TEE ultrasound probes. Our core product, the TD 100, and our newest product, TEEClean, are examples of our ongoing commitment to innovation and to the health and safety of medical patients and staff.

Beyond high-level disinfection of TEE probes, CS Medical believes in managing the quality of care given to delicate TEE probes. Our product offering provides solutions for the healthcare facility to minimize TEE ultrasound probe damage and reduce the potential of contaminating high-level disinfected probes prior to use. The products address the following areas: bedside cleaning, electrical leakage testing, drying, transporting and storing the TEE ultrasound probe. Our objective is to manage the care given to each TEE probe thus allowing for a reduction in healthcare associated infections.

Our products incorporate temperature critical fluidics, microprocessor control and data transfer, interactive human interface and electromechanical design components. The company installs and services its systems throughout North America and has international distributors in countries worldwide.  We operate in an ISO 13485 quality environment and are an FDA registered manufacturer.

CS Medical seeks to provide a challenging, yet rewarding work environment with a focus on manufacturing a quality product and teamwork. Opportunities for career development depend only upon the willingness of the employee to tackle challenges and demonstrate responsibility and initiative. Located in Creedmoor, CS Medical is a short, low-traffic commute from Raleigh and Durham, and just a few miles from Falls Lake State Recreation Area.  This is an excellent opportunity to work for a top-notch employer that values the development and growth of their employees.

With continued business growth and expanding global initiatives, CS Medical has an immediate opportunity for a full-time QA / RA Manager.  The QA / RA Manager will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, and regulatory agency interaction during product development. QA / RA Manager will also ensure that CS Medical’s quality system achieves conformity with ISO 13485, FDA CFRs, and other international authorities.
 

JOB TASKS, DUTIES, AND RESPONSIBILITIES

JOB DUTIES:

  • Coordinates and prepares moderately complex regulatory submissions for electromechanical disinfectors with chemical disinfectants that includes 510(k) premarket notifications, EU Technical Files, Health Canada Submissions, among other international submissions.
  • The QA / RA Manager plans long term strategies for verification and validation activities of new products and directs validation activities for special processes as CS Medical manufactures new medical devices.
  • Also interfaces and supports Global Registrations and other documentation required for registration of products outside America. Interfaces as needed with FDA, Notified Bodies or other national health agencies regarding new products and significant changes to products.
  • The QA / RA Manager is responsible for maintaining the health of the quality system.
     
  • Provides a regulatory expertise and oversight to engineering design teams.
    Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management, and product labeling as they relate to registration and commercialization of medical devices.
  • Ensures compliance with design controls and reviews design documentation to ensure regulatory requirements are met.
     
  • Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale. 
  • Liaise with selected standards agencies, testing labs and regulatory authorities to ensure timely completion of regulatory activities, provision and filing of evidence of compliance, and resolution of compliance issues.
  • Monitors FDA and other government agency laws and regulations through websites and publications.
  • Brings Quality Assurance and Regulatory Affairs questions/issues to the attention of Vice President, General Manager.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

MINIMUM QUALIFICATIONS

  • Bachelor’s degree in a science, healthcare or engineering field
  • At least 10 years of overall Medical Device Quality Assurance or Regulatory Affairs experience; Domestic and/or International
  • Knowledge and experience of Class II medical device software development
  • Knowledge and experience of quality management systems and standards such as ISO 13485, 21 CFR 820 (U.S. QSR), EU MDR and Health Canada
  • Excellent English language skills both verbally and writing
  • Good knowledge of Microsoft Office
  • Strong organizational skills
  • Strong managerial skills

 

PREFERRED QUALIFICATIONS

  • Experience in ultrasound in clinical settings
  • Experience in infection control in clinical settings
  • 510k experience with high level disinfectants
  • 510k experience with electromechanical medical device with embedded software
  • MDR submission experience

 

LOCATION

This position will be based at our Creedmoor, NC offices.

 

TERMS OF EMPLOYMENT

This is a full-time, exempt, salaried position. 

 

HOURS

The general hours shall be Monday – Friday, 9:00am to 3:00pm.  As a salaried employee you are expected to work at least forty (40) hours per week.  Our flex schedule policy applies to you.  You can flex around the core hours listed above to complete the remaining required hours in the office.  

 

WORK ENVIRONMENT

Work is regularly performed in office and warehouse environments.

 

PHYSICAL DEMANDS  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  The employee is frequently required to sit.  The employee is occasionally required to stand and/or walk.  The employee must occasionally lift, carry, push or pull up to 20 pounds. 

 

TRAVEL

Minimal travel may be required. 

 

BENEFITS

Compensation package following introductory period includes:

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Teladoc Benefits
  • Life Insurance
  • Short term disability
  • Employee Assistance Program
  • 401K plan With Employer Contribution (both traditional and Roth options)
  • Company Paid Holidays
  • 2 weeks of Paid Time Off Available at Start of Employment

 

HOW TO APPLY

To apply for this position, please submit your resume and cover letter. CS Medical is an equal opportunity employer.​ CS Medical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, age, disability or genetic information.  For further information about us please visit our website at www.csmedicalllc.com.


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Job At-a-Glance
Employment Type: Full-Time
Education: Bachelor's Degree
Experience: At least 10 years of QA/RA medical device exp
Manages Others: Yes
Required Travel: Yes