Quality and Regulatory Engineer

Quality and Regulatory Engineer 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 and 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. This is a full‑time, exempt hybrid position based in Glenwood, IL, also supporting the Solon, OH site. Responsibilities Maintain, implement, and improve the Quality Management System (QMS) in alignment with ISO 9001, ISO/IEC 17025, NQA‑1, and 10 CFR 50 AppendixB requirements. Handle complaints, non‑conformances, corrective/ preventive actions, and material review board activities. Ensure effective interactions at department level and cross‑functionally to 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. Assist in the development of essential QMS deliverables such as 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 R&D to manufacturing, including participation and leadership of equipment and process validation requirements (FMEA, IQ, OQ, PQ) 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. 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 ISO9001:2015, ISO17025:2017; experience with NQA‑1 and 10CFR50 AppendixB 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, 5Whys, control charts, etc.). Familiar with Six Sigma, process excellence methods, risk management (ISO14971) 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. Benefits & Compensation This position is eligible for a bonus as part of the total compensation package. The salary range for this position is 88,000.00–147,000.00 local currency. Equal Opportunity Employer 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 View email address on click.appcast.io. #J-18808-Ljbffr Fortive