Quality Engineering - Safety and Compliance

As a Quality Engineer on the Fluke Health Solutions Quality Assurance/Regulatory Affairs team, you will be responsible for ensuring compliance with FDA/GMP/QSR, ISO 9001/13485/17025 and other applicable regulatory standards. 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.

Internal: Quality Assurance and Regulatory Affairs team, Operations team, Engineering team, Business Units as well as all other functional team members.

Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers.

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 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 the development of essential QMS deliverables including 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, participate in investigations, root‑cause analyses, corrective action planning, implementation activities and interface with all cross‑functional departments to increase product quality using 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.

BA/BS in Engineering or physical sciences preferred. Bachelor’s degree preferred. 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 such as Flow Charts, Pareto Charts, Histogram, Control Charts, Ishikawa Diagram, 5 Whys.

Business/financial acumen.

Six sigma and process excellence tools/methodologies.

Strong Quality Engineering skills with working knowledge of product design verification as well as product and process validation activities.

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 across 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 knowledge of regulatory requirements.

Proficient knowledge of risk analysis and identification of effective risk controls; understanding of risk management regulations and guidance standards such as ISO 14971, ISO 31000, FDA Guidance and tools like System Risk Analysis, FMEA, and FTA.

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. 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. 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. 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 must contact us at View email address on click.appcast.io or Equity

This position is also eligible for bonus as part of the total compensation package.

The salary range for this position (in local currency) is 81,190.00 - 135,585.00.

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