MagnaWave Inc Logo
MagnaWave Inc Logo

MagnaWave Inc

Quality & Regulatory Manager

Jeffersontown, KY

MagnaWave Inc's definition

In 2002, Pat Ziemer began introducing MagnaWave PEMF therapy to the horse community. He knew that life truly is what you make of it and he knew the wonderful, non-invasive, non-pharmaceutical method was needed. He wanted his business to foster an attitude and environment to succeed for everyone who joined this company.

We have since that time tried to create a place that was designed with this value in the forefront. A company where incredibly talented individuals are empowered to put their best work into helping people who are seeking health, wellness and prosperity. As MagnaWave continues to grow, we hope that our principles will serve each new person who joins the company. Although company policies are important; it is really your ideas, talents and energy that will keep MagnaWave shining in the years ahead. Thanks for being here; let’s make great things!

MagnaWave Inc's "why"

To have a company where incredibly talented individuals are empowered to put their best work into helping people who are seeking health, wellness and prosperity.

MagnaWave Inc's mission statement

Our quality policy is that the employees and management of MagnaWave are committed to consistently provide the highest quality products and services that will satisfy the demands and expectations of customers by continual improvement of the Quality Management System and conforming to all industry standards and prevailing codes of practice.

Core values include:
** Reliable - Produce the safest products in the marketplace and fulfill orders in a manner that is above expectations.

** Driven - Go above and beyond for our clients and each other.

** Innovative - We all take initiative to continuously improve ourselves, and our work.

** Adaptive - Have open communication to point out issues and concurrently offer solutions. If you see a problem, find the solution.

** Accessible - Make sure every customer has a personal experience.
Communication is free flowing; if you have a problem, go to the source. We check our egos at the door.

Jeffersontown, KY
Full Time
$92,000 – $97,000 / year

Overview

Job Description:

MagnaWave is much more than a product, we are a family! We are currently seeking a Quality and Regulatory Manager to join our growing team.

MagnaWave has been working with PEMF (Pulsed Electro-Magnetic Fields) equipment for 15+ years. Based in Louisville, KY, United States, we are proudly family-owned and operated. Our organization has a reputation for outstanding leadership, innovation, and expertise. Plus, we believe in having a little fun along the way with various team-building events, lunches, team recognition, casual dress, flexible work arrangements, and special events.

Our goal is to hire the right talent in the right place; to develop leaders and shape our future talent pools to help us meet the needs of our customers world-wide. Join us and share your own ideas about how we can grow our business and provide an exceptional employee experience!

Overview:

The Quality & Regulatory Manager owns, audits, and drives improvements within the MagnaWave Quality Management System (QMS). The Quality and Regulatory Manager will manage the organizations’ registrations, applications, readiness to enter new markets (domestic and international), and the company’s compliance with standards and requirements in all markets.

Duties & Responsibilities

Duties & Responsibilities:

*  Develop regulatory strategies

*  Serve as official FDA correspondent

*  Host all FDA and regulatory agencies audits, complete annual registrations

*  Assess need for regulatory registrations 

*  Manage all quality procedures & supporting documentation

*  Responsible for the Document control process and the efficient control of all documentation required by regulatory agencies; provide recommendations for continuous improvement of document change control and document retention. 

*  Audit all quality procedures & supporting documentation as scheduled to ensure compliance

*  Conduct internal reviews/audits to ensure the QMS is being implemented appropriately

*  Manage corrective and preventative action procedures

*  Conduct ongoing company-wide training on FDA and ISO requirements.

*  Verify that all quality and regulatory policies and procedures have been documented, implemented, and communicated

*  Manage the complaint handling process and nonconforming material process

*  Manage supplier qualification activities and monitor performance

*  Remain educated and up-to-date on regulations

Qualifications

Education and Experience:

  • High School Diploma required; some college preferred
  • Certification in Quality or Regulatory Systems preferred; FDA and ISO 13485 experience helpful
  • Knowledge and experience in technical writing and/or government submissions
  • Project management experience preferred
  • Knowledge of Core platform or similar documentation software/programs
  • Excellent verbal and written communication skills, able to communicate effectively with all levels within the organizations

Physical Demands:

  • May be frequently required to sit or stand for periods of time
  • May be required to push, pull, or lift objects up to 50 lbs.
  • Ability to travel (domestic and international) as company grows (<10%)