Quality Specialist

Fortive

  • Cleveland, OH
  • Permanent
  • Full-time
  • 9 days ago
As a Quality Specialist on our Fluke Health Solutions Quality Assurance team, you will be responsible for ensuring compliance with established NQA1, 10CFR 50 Appendix B, ISO 9001 and other applicable regulatory standards and requirements. We are seeking a dedicated and detail-oriented Quality Specialist to join our team. The Quality Specialist will be responsible for overseeing incoming, in-process, and final inspection activities, managing supplier quality, assisting with problem-solving using various tools, manage training documentation, and ensuring compliance with NQA-1 standards.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:
  • Perform and oversee incoming inspections of raw materials, components, and finished products.
  • Conduct in-process inspections to ensure compliance with quality standards.
  • Perform final inspections to verify that finished products meet specified requirements.
  • Document inspection results and maintain records.
  • Evaluate and monitor supplier performance to ensure consistent delivery of quality materials.
  • Coordinate the 'Supplier Corrective Action Request' (SCAR) program including monitoring response timeliness and effectiveness of corrective actions. Collaborate with suppliers to resolve quality issues and implement corrective actions.
  • Conduct supplier audits, surveys and assessments as required as per 10CFR50 Appendix B.
  • Assist in identifying and resolving quality-related issues using problem-solving tools (e.g., 5 Whys, Fishbone Diagrams, Root Cause Analysis).
  • Initiate NCRs and SCARs and work with cross-functional teams to address quality concerns and implement improvements. Track and report on the effectiveness of corrective and preventive actions.
  • Ensure all quality personnel are adequately trained and maintain training records.
  • Maintain compliance with NQA-1 standards and ensure all processes and procedures align with regulatory requirements.
  • Participate in internal and external audits to ensure ongoing compliance with NQA-1 standards.
  • Assist site quality manager to schedule and prepare management review meetings.
  • 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.
  • 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, and/or ASQ certifications accepted.
  • 5+ years of experience in a Quality Specialist role within a manufacturing environment.
  • Knowledge of quality inspection methods, tools, and equipment.
  • Strong problem-solving skills and experience with problem-solving tools.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong attention to detail and organizational skills.
  • Proficiency in Microsoft Office Suite and Quality Management Software.
  • Must have knowledge of the, ISO 9001:2015, and/or NQA1 standards
  • Prior experience with 10CFR50 Appendix B is highly preferred.
  • NQA1 Lead Quality Auditor is highly preferred.
#LI-ES1Fortive Corporation OverviewFortive'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 SolutionsComprised 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.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 applyassistance@fortive.com.Pay Range
The salary range for this position (in local currency) is 52,200.00 - 96,900.00

Fortive