Regulatory and Quality Assurance Project Coordinator

Alma Lasers, Inc.

Buffalo Grove, Northern (IL, KY)

Hybrid

USD 70,000 - 75,000

Full time

9 days ago
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Job summary

Alma Lasers, Inc. in Buffalo Grove, IL is seeking a Regulatory and Quality Assurance Project Coordinator for an on-site, full-time role.

The position supports QA/regulatory milestones, data tracking, and documentation across teams to ensure compliance and continuous improvement. Requirements include a Bachelor’s degree or equivalent experience; ERP (NetSuite) experience and familiarity with FDA-regulated medical devices are preferred.

Qualifications

  • Bachelor’s degree or equivalent experience.
  • ERP (NetSuite) experience preferred.
  • FDA/Health Canada regulated medical device environment preferred.
  • On-site in Buffalo Grove, IL required.
  • Strong organizational and communication skills.

Responsibilities

  • Coordinate complaint investigations with internal departments.
  • Track metrics and data collection.
  • Develop training materials, agendas, and minutes.
  • Support the management of audits, preparation, conduction, and follow-up.
  • Work with clinical, sales, customer service, and field service on equipment related to patient care.
  • Provide support for QA/Regulatory documentation and follow-up.

Skills

MS Office
Excel
PowerPoint
Outlook
Organizational Skills
Emotional Intelligence
Multitasking
Communication Proficiency

Education

Bachelor’s degree or equivalent experience

Tools

NetSuite ERP

Job description

# Regulatory and Quality Assurance Project CoordinatorBuffalo Grove, Illinois, US · Full-time · Associate**Workplace type**Hybrid#### About The Position**Job Description****Regulatory and Quality Assurance Project Coordinator**Salary range is $70,000 - $75,000, commensurate with experienceCorporate Headquarters485 Half Day Rd. Ste 100Buffalo Grove, IL 60089***This is an onsite position, full-time located in Buffalo Grove, IL.*****About Alma Lasers**Alma, a Sisram Medical company, is a global leader in medical-aesthetic technologies with over 25 years of experience in energy-based devices (EBD). Operating in more than 100 countries worldwide, Alma combines advanced technology, clinical expertise, and a holistic approach to aesthetic and wellness care.In the U.S., Alma Lasers is one of the most trusted brands among physicians, clinics, and consumers—delivering innovative, science-based solutions for skin rejuvenation, body contouring, hair removal, and other aesthetic applications.**Summary**The Regulatory and Quality Assurance Project Coordinator works under minimal supervision and is responsible for providing day-to-day coordination of activities that enforce continuous monitoring and improvement of systems, ensure QA / Regulatory milestones and deliverables are met, and assure quality and compliance of the Regulatory and Quality team.This is a deadline driven role, needing strong organizational and time management skills!*This position is on-site, and we are looking for good people who want to be a part of the amazing culture here at Alma!***Essential Functions***Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.** Coordinate and collaborate with internal departments for complaint investigation.* Responsible for Metrics tracking and data collection.* Develop and support general training/meeting materials, including invitations, agendas, and minutes.* Compile reports from select QA/Reg databases, Keeping QA/Reg leadership informed of any concerns.* Support the management of the adverse events and ensure issues are reported accurately.* Follow-up with project teams for supporting documentation and ensure QA/Regulatory recommendations are provided, as directed by QA/Reg leadership.* Support the preparation and organization of essential document folders, package trackers, and electronic data upload and entry.* Provide support for all audit activities to include preparation, conduction, and follow-up.* Work closely with clinical, sales, customer service, and field service on equipment as it pertains to direct patient care.**Competencies*** Initiative* Problem Solving/Analysis* Technical Capacity* Organizational Skills* Communication Proficiency* Ability to retain large amounts of information* Project Management**Education and Experience Required*** Bachelor’s degree or equivalent experience* ERP (NetSuite) experience preferred* Experience in the FDA and Health Canada regulated medical device environment is preferred, but not required**Skills Required*** Positive attitude and approach to the job responsibilities and the Alma team* Microsoft Applications (MS Office, Excel, PowerPoint, and Outlook)* Excellent organizational skills* Emotional Intelligence* Ability to multitask* Ability to work on-site in Buffalo Grove, IL (Corporate Office)**Supervisory Responsibility**This position has no direct reports but assists in mentoring peers and other departments as needed.**Work Environment**This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. You will be working with sensitive patient images.**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 must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.**Travel**This position requires 0% travel as needed.**Work Authorization**Documentation showing eligibility to work in the United States will be required.**Other Duties**Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.**Alma, Inc. is Equal Opportunity Employment:**We're proud to be an equal opportunity employer and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status.**E-Verification:**In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
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