The Quality Management Systems (QMS) Professional will assist the QMS Quality Assurance/Regulatory Assurance Manager in the running of the global Quality Management System, including sustainment and process improvement activities for the organization. This position is an integral part of Fluke’s global QMS for achieving our goals and ensuring compliance with internal policies, industry standards and applicable regulation.
Essential job functions
Document Control
Coordinates all document control activities related to Fluke’s Global QMS using our software system for effective control, distribution, and retention of QMS documents and records.
Assists functional leaders and process owners in the creation of documents including policies, procedures, work instructions and forms while ensuring consistency and quality of content.
Works with Quality, Metrology, Product Compliance, Environmental Compliance, and all relevant functional groups to ensure Fluke’s QMS documentation accurately defines pertinent requirements.
Coordinates with organizational process owners to ensure effective and efficient rollout of policies and change initiatives by communicating across Fluke functions.
Participates in all QMS activities including, but not limited to, performing routine review of quality control documentation, and the development and execution of validation documentation.
Quality Assurance
Uses existing platforms for QMS activities including document control, audits, and nonconformances.
Uses expertise in standards and regulatory requirements to lead special projects related to establishing consistent policies across the global organization as required.
Supports and/or performs internal and external audit activities. Assists in preparation and hosting of regulatory audits.
Participates in the development, monitoring and improvement of QMS Key Performance Indicators and finds opportunities for improvement and to minimize risk.
Assists with timely and appropriate closure of non-conformance reports (NCRs) in accordance with internal policy. This may include using quality tools such as Root Cause Analysis, fishbone, scatter diagram, etc.
Supports the planning, coordination, and presentation of QMS training and educational programs.
Assists with the creation and promotion of internal SharePoint sites which provide easy accessibility to a single source of QMS information.
Maintains the internal SharePoint site for standard responses to customer requests for QMS information.
Qualifications
Knowledge, skills and abilities
Experience in creating and implementing quality policies and procedures in compliance with applicable regulations and standard.
Strong problem-solving skills.
Multi-tasking (i.e. comfortable working on multiple projects with high priority while achieving established goals).
Excellent written and verbal communication skills, including the ability to prepare correspondence, documents, and presentations with minimal direction.
Strong attention to detail and good follow through.
Comfortable working both in a team environment and independently and the ability to lead by influence.
Solid understanding of personal computers with superior skills in desktop programs (e.g., Outlook, Word, Excel, SharePoint, Project, Visio, Power Point, and other comparable software programs).
Ideal candidate will have desire and growth potential for additional leadership roles within Quality.
Education, experience & job requirements
Bachelor’s Degree from an accredited university/college or equivalent work experience required.
Minimum of 2 years of Quality-related experience required.
Regulatory and/or ISO experience required.
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 18,000 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.
Ready to move your career forward? Find out more at careers.fortive.com (https://stgfortive.taleo.net/enterprise/careers.fortive.com) .
Fluke is leading the world in creating software, test tools and technology that will support customers today and in the future . We are a customer-obsessed market leader with a strong reputation for reliability, quality and safety.
A wholly owned subsidiary of Fortive Corporation ( www.fortive.com ), Fluke is a global corporation headquartered in the greater Seattle area. Driven by the successful Fortive Business System, Fluke offers the passion of a startup with the resources of a Fortune 500 company. We are focused on the growth of our individual employees, teams, and the Fluke brand.
We Are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should ask to speak with a Human Resources representative to request an accommodation.
Everett, WA: The salary range for this position is $91655 - $170085
This position is also eligible for bonus as part of the total compensation package.
Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.