Quality Engineer

Description As a Quality Engineer on our Fluke Health Solutions Quality Assurance/Regulatory Affairs team, you will be responsible for ensuring compliance with established FDA/GMP/QSR and ISO 9001/13485/17025 and other applicable regulatory standards and requirements. 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. 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, FDA, Suppliers. Responsibilities Ensure appropriate document control process is in place as it relates to medical activities. 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 in order to provide ideas, methods, or processes for site/corporate performance improvement. Assists 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. Execute New Product Introduction/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 Determine test requirements, test methods, sample sizes and statistical analysis for qualification/verification studies for manufacturing Conduct and document internal audits and gap analyses against specified requirements. Manage CAPA efforts and interact with internal and external customers to conduct investigations. Collect, analyze, and assemble pertinent quality data for periodic reviews. Participate in and support external audits as required. Perform other job-related duties as assigned. Qualifications BA/BS in Engineering or physical sciences preferred. Bachelor's degree preferred. Equivalent experience, and/or ASQ certifications accepted. 3-5 years of related experience required Must have knowledge of the one or more of the following: FDA QMSR, ISO 13485:2016, ISO 9001:2015, and/or ISO 17025:2017 Must have knowledge and experience in quality engineering concepts, including working knowledge of current process control and validation principles Must be able to collaborate with other functions to collect and analyze data and conduct trending analysis. Must have experience with Complaint, Nonconformance, Corrective/Preventive Actions, and Material Review Board processing. Experience using standard quality tools i.e. Flow Charts, Pareto Charts, Histogram, Control Charts, Ishikawa Diagram, 5 Whys. Business/financial acumen Six sigma and process excellence tools/methodologies Presentation skills and use of Power Point Strong Quality Engineering skills with working knowledge of product design verification as well as product and process validation activities Ability to communicate in a cross-cultural environment Ability to effectively prioritize and manage multiple activities and responsibilities. Self-motivated. Leadership ability in using problem solving techniques including root cause analysis and cause and effect analysis Leadership ability in improving product reliability for products in partnership and various departments, such as R&D, Operations, Service Fluent in MS Word and Excel Strong working knowledge of industry standards such as IEC 62304, IEC 60601-1, IEC 61010, IEC 62353, various EMI/EMC requirements and/or knowledge of both regulatory requirements and other compliance areas Proficient knowledge of both risk analysis and identification of effective risk controls. Strong understanding of appropriate Risk Management regulations and guidance standards, such as ISO 14971, ISO 31000, and FDA Guidance and thorough understanding in the application of risk management tools, such as System Risk Analysis, FMEA, and FTA. Fortive Corporation Overview 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. 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. 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. 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 81,190.00 - 135,585.00 #J-18808-Ljbffr Fluke Health Solutions