Quality Engineer

As a Quality Engineer on the Fluke Health Solutions Quality Assurance/Regulatory Affairs team, you will ensure compliance with established FDA/GMP/QSR, ISO 9001/13485/17025, and other applicable regulatory standards. Your role is critical in preventing legal enforcement actions, schedule delays, or disruptions to departmental operations and overall business activities.

Primary Contacts

• Internal: Quality Assurance and Regulatory Affairs team, Operations team, Engineering team, Business Units, and all other functional team members.
• External: Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers.

Responsibilities

• Ensure appropriate document control processes for medical activities.
• Handle Complaints, Non-Conformances, Corrective/Preventive Actions, and Material Review Board activities.
• Facilitate effective interactions at the departmental and cross-functional levels to align activities with site/company strategies and quality systems.
• Participate in project teams and meetings to provide ideas, methods, or processes for site/corporate performance improvement.
• Assist in developing essential QMS deliverables, including complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation.
• Support the site quality manager in scheduling and preparing management review meetings.
• Coordinate the ‘Supplier Corrective Action Request’ (SCAR) program, monitoring response timeliness and effectiveness of corrective actions.
• Execute New Product Introduction/Design Transfer activities, characterizing manufacturing processes for parts/components in development to ensure smooth transition from Research & Development to manufacturing. Lead the development of equipment and process validation requirements (FMEA, IQ, OQ, PQ) using statistical tools and techniques.
• Spend time on the manufacturing floor to identify process improvements, participate in investigations, root cause analyses, corrective action planning, and implementation. Interface with cross-functional departments to enhance product quality using Six Sigma and Lean methodologies.
• Determine test requirements, test methods, sample sizes, and statistical analysis for qualification/verification studies in 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.

Requirements

• BA/BS in Engineering or physical sciences preferred; equivalent experience and/or ASQ certifications accepted.
• 3-5 years of related experience.
• Knowledge of one or more of the following: FDA QMSR, ISO 13485:2016, ISO 9001:2015, and/or ISO 17025:2017.
• Experience with quality engineering concepts, including process control and validation principles.
• Ability to collaborate with other functions to collect and analyze data and conduct trending analysis.
• Experience with Complaint, Nonconformance, Corrective/Preventive Actions, and Material Review Board processing.
• Proficiency with standard quality tools (Flow Charts, Pareto Charts, Histogram, Control Charts, Ishikawa Diagram, 5 Whys).
• Business/financial acumen.
• Experience with Six Sigma and process excellence tools/methodologies.
• Strong presentation skills and proficiency in PowerPoint.
• Working knowledge of product design verification, product and process validation activities.
• Ability to communicate in a cross-cultural environment and effectively prioritize multiple activities.
• Self-motivated with leadership ability in problem-solving techniques, including root cause analysis and cause-and-effect analysis.
• Leadership in improving product reliability in partnership with R&D, Operations, and Service departments.
• Fluent in MS Word and Excel.
• Working knowledge of industry standards such as IEC 62304, IEC 60601-1, IEC 61010, IEC 62353, and EMI/EMC requirements.
• Proficient knowledge of risk analysis and identification of effective risk controls.
• Strong understanding of Risk Management regulations and guidance standards (ISO 14971, ISO 31000, FDA Guidance) and application of risk management tools (System Risk Analysis, FMEA, FTA).

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: The worldwide leader in X-ray test equipment, real-time staff dosimetry, and radiation survey meters.
• Victoreen: The trusted source for radiation monitoring systems and quality assurance for nuclear power professionals.

Benefits

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

Pay

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