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Full-time
bachelor degree, professional certificate
Paid Time Off, Paid Holidays, Medical Insurance, Dental Insurance, Vision Insurance
Posted 47d ago
~40 hrs/week
Responsibilities
Maintain and improve the Quality Management System in compliance with ISO and nuclear grade standards. Oversee regulatory activities, handle non-conformances, and lead CAPA efforts to ensure product and laboratory quality.
Requirements
Requires a degree in Engineering or Physical Sciences with 4-5 years of quality or regulatory experience. Proficiency in ISO standards, quality tools, and process validation is essential, with radiation dosimetry experience highly preferred.
Full job description
As a Quality and Regulatory Engineer on our Fluke Health Solutions Quality Assurance/Regulatory Affairs team, you will be responsible for maintaining compliance with ISO 17025, NQA‑1, 10CFR 50 Appendix B, ISO 9001 and other applicable regulatory Agencies (NUPIC) & standards. This role drives continuous improvement, oversees regulatory compliance activities, supports audits, and ensures that products, services, and laboratory results meet the highest standards of technical competence and nuclear grade quality assurance. Failure to identify and recommend corrective actions could result in legal enforcement action, critical delays in schedules and/or departmental operations and may jeopardize overall business activities.
This is a full-time, exempt hybrid position based in Glenwood, IL, also supporting Solon, OH site. Fluke Health Solutions offers competitive salary, time off, and benefits. Our offering includes PTO, paid holidays, medical/dental/vision on Day 1 + many more. We want you to bring your whole self to FHS!
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: Industry peers, Regulatory agencies, Customers, Notified Body, Suppliers.
Responsibilities:
Maintain, implement, and improve the Quality Management System (QMS) in alignment with ISO 9001, ISO/IEC 17025, NQA‑1, and10 CFR 50 Appendix B requirements.
Handle Complaints, Non-Conformances, Corrective/Preventive Actions, and Material Review Board activities.
Ensure effective interactions at department level and cross-functionally to effectively incorporate departmental activities into overall site/company strategies and quality systems.
Participate in project teams and meetings on behalf of the Global Quality & Regulatory Team to provide ideas, methods, or processes for site/corporate performance improvement.
Assists in the development of essential QMS deliverables including, but not limited to complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation.
Assist site quality manager to schedule and prepare management review meetings.
Coordinate the ‘Supplier Corrective Action Request’ (SCAR) program including monitoring response timeliness and effectiveness of corrective actions.
Chair the CAPA meeting, coordinate/lead CAPA efforts, and interact with internal and external customers to conduct investigations.
Conduct and detail internal audits and gap analyses against specified requirements.
Collect, analyze, and assemble pertinent quality data for periodic reviews.
Participate in and support external audits as the need arises.
Develop, revise, and control quality procedures, work instructions, and technical documentation.
Execute New Product Introduction (FAI)/Design Transfer activities in characterizing manufacturing processes for parts/components in development to ensure smooth transition from Research & Development to manufacturing, including participation and leadership of the development of equipment and process validation requirements (Failure Modes and Effects Analysis, Installation Qualification, Operational Qualification, Performance Qualification), using appropriate statistical tools and techniques.
Spend time on the manufacturing floor to determine process improvements, participating in investigations, root cause analyses, corrective action planning, implementation activities and interfacing with all cross functional departments to increase product quality using recognized Six Sigma and Lean methodologies.
Collect, analyze, and assemble pertinent quality data for periodic reviews.
Perform other job-related duties as assigned.
Qualifications:
BA/BS in Engineering or Physical Sciences preferred; equivalent experience or ASQ certifications accepted.
4–5 years of relevant quality or regulatory experience.
Working knowledge of ISO 9001:2015, ISO 17025:2017; experience with NQA‑1 and 10 CFR 50 Appendix B preferred.
Radiation dosimetry experience is highly preferred.
Certified Auditor highly preferred.
Strong background in quality engineering, GMP principles, product verification, and process validation.
Skilled in data analysis, trending, and cross functional collaboration.
Experience with complaints, nonconformances, CAPA, and MRB processes.
Proficient with quality tools (Pareto, Ishikawa, 8D, 5 Whys, control charts, etc.).
Familiar with Six Sigma, process excellence methods, risk management (ISO 14971) and FMEA.
Strong communication, presentation, and leadership skills; able to manage multiple priorities independently.
Proficient in MS Word, Excel, and PowerPoint; solid business and financial acumen.
Ability to work effectively in cross-cultural environments and partner with R&D, Operations, and Service teams to improve product reliability.
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.
About Fluke Health Solutions
Fluke Health Solutions (FHS), an operating company of Fortive, is comprised of 3 industry leaders – LANDAUER, Fluke Biomedical, Victoreen, and RaySafe. We lead the biomedical and radiation detection markets with innovative products and services to keep customers, patients, and clients safe. Our portfolio of products includes software, biomedical test equipment, radiation measurement and radiation detection.
The Fluke Health Solutions vision is to empower our everyday heroes to focus only on protecting lives.
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 application process, please contact us at [email protected].
Related keywords
ISO 9001ISO 17025NQA-110 CFR 50 Appendix BNUPICQMSCAPAMRBSCARFMEAIQ/OQ/PQSix SigmaLeanISO 14971Radiation DosimetryGMP
Appliances, Electrical, and Electronics Manufacturing
Company size
10,001+ employees
Headquarters
Everett, Washington
LinkedIn followers
111,047
Total funding
$2.4B
Fortive’s essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. 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 advanced technologies that help providers focus on exceptional patient care.
We are a diverse team 10,000 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.
Recruitment fraud alert: Fortive has been made aware of candidates receiving fraudulent job opportunities from unauthorized recruiting agencies or people impersonating Fortive leaders. We take this matter very seriously and are taking all appropriate measures to address this. Learn more: https://careers.fortive.com/recruitment_fraud
Offices: 6920 Seaway Blvd, Everett, Washington 98203, US
Professional InstrumentationIndustrial TechnologiesHealthcare SolutionsSoftware-Enabled Workflow Solutionsand Workplace SafetyElectronicsRoboticsIndustrial ManufacturingAutomotiveIndustrial Automation
How much do Security & Safety jobs in Illinois pay?
Based on 1905 listings with disclosed salaries, most security & safety jobs in Illinois pay between $70k–$169k per year. Individual offers vary with seniority, company size, and specialization.
How many Security & Safety jobs are open in Illinois right now?
There are currently 6,018 open security & safety positions in Illinois listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Security & Safety roles in Illinois?
Companies currently hiring include Allied Universal, First Student, Northrop Grumman, Centurion Health, Illinois Department of Children and Family Services, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Security & Safety jobs in Illinois?
Yes — 759 of the 6018 open security & safety positions offer remote or hybrid work (242 remote, 517 hybrid).
How do I apply for Security & Safety jobs in Illinois?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.