Description:

 

As a Document Control Coordinator on our Fluke Health Solutions Quality Assurance/Regulatory Affairs team, you will be responsible for the administration of the quality document control process and ensure alignment with applicable standards and country specific regulations. You will be a champion for quality and compliance in our business, integrating into all design and manufacturing functions to streamline documentation processes. This person will administrate the quality software system ensuring documentation is maintained and compliant for business needs.

Your primary contacts will be:

Internal: Quality Assurance and Regulatory Affairs team, Operations team, Engineering team, Business Units as well as all other functional team members.

External: Customers, Notified Bodies, or Suppliers 

Responsibilities:

Administrate quality software system and document control process, including acting as project manager to lead minor change control projects. Coordinate and maintain controlled documentation, both physically and electronically, according to approved procedures. Assist with file migration to storage, both physically and electronically, as applicable. Coordinate and execute the migration of legacy documentation stored outside of the existing eQMS into a new eQMS system Ensure all documents are current, properly identified, and maintained per applicable standards and regulations. Aid in investigation and improvement initiatives for quality processes. Review records and documents for completeness and compliance with FDA Quality System Requirements and ISO requirements. Assist in company-wide training on general quality principles and specific procedural requirements. Other activities as assigned by supervision including cross-training in other areas of quality and regulatory as applicable. Develops and reports document control, change control and training key performance indicator metrics and change management statistical information to management team. Assist and support internal audits and agency inspections/audits.

 

Qualifications:

Minimum of a bachelor’s degree in a life sciences, healthcare, or technology discipline (Preferred) Relevant experience in the medical device industry is required Familiarity with FDA medical device regulations and ISO 13485 is required Experience in QA document control process administration required Experience with effective project management preferred 3+ years with Document Control experience working in an eQMS platform (e.g., Propel PLM, Oracle Cloud, Arena PLM, or SoftExpert) Ability to read and interpret general technical/quality procedures and quality system regulations Ability to write and create medical device manufacturing SOPs and Work Instructions Ability to effectively present information and respond to questions verbally, in writing, and in group presentations Must be skilled in Microsoft Word, Excel, Outlook, and Power Point

Position Type/Expected Hours of Work

This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours.  This position will start out on-site, however, a hybrid schedule will be considered after a few months for this role.

 Travel

No significant travel should be expected for this position

Fortive Corporation Overview

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 17,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

About Fluke Health Solutions

Comprised of four industry leaders—Fluke Biomedical, LANDAUER, RaySafe, and Victoreen — Fluke Health Solutions (FHS) leads the biomedical and radiation detection markets with innovative products and services that help keep customers, patients, and clients safe. Fluke Biomedical leads the world in manufacturing biomedical test equipment like defibrillator analyzers and digital pressure meters. LANDAUER measures radiation exposure with dosimeter and radiation monitoring badges. RaySafe is the worldwide leader of X-ray test equipment, real-time staff dosimetry, and radiation survey meters. And Victoreen instruments are the trusted source for radiation monitoring systems and quality assurance for nuclear power professionals. At FHS, we believe in your potential — your ability to learn, grow and contribute in meaningful ways. And we believe in giving you the opportunity, accountability, and visibility to do just that.

Bonus or Equity
This position is also eligible for bonus as part of the total compensation package.

Pay Range
The salary range for this position (in local currency) is 81,200.00 - 150,800.00

Is this role subject to ITAR?
The essential duties of this position require adherence to U.S. Government export control regulations. Accordingly, candidates must either be U.S. Persons (i.e., U.S. citizens, U.S. lawful permanent residents, or protected individuals as defined by 8 U.S.C. 1324b(a)(3)) or be prepared to collaborate with the company in securing the necessary U.S. government export authorizations. While the company encourages all interested applicants to apply, please be aware that ongoing employment is dependent upon obtaining the appropriate government export authorizations.