Quality and Regulatory Engineer

Job Description Template

Description: 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 NQA1 10CFR 50 Appendix B ISO 9001 and other applicable regulatory Agencies (NUPIC) & 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. 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.

This is a full-time exempt hybrid position based in Glenwood IL also supporting Solon OH site. Fluke Health Solutions offers competitive salary time off and benefits. Our offering includes PTO paid holidays medical/dental/vision on Day 1 many more. We want you to bring your whole self to FHS!

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:

• Maintain implement and improve the Quality Management System (QMS) in alignment with ISO 9001 ISO/IEC 17025 NQA1 and 10 CFR 50 Appendix B requirements.
• 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 to provide ideas methods or processes for site/corporate performance improvement.
• Assists in 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.
• 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 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.
• 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 or ASQ certifications accepted.
• 45 years of relevant quality or regulatory experience.
• Working knowledge of ISO 9001:2015 ISO 17025:2017; experience with NQA1 and 10 CFR 50 Appendix B 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 5 Whys control charts etc.).
• Familiar with Six Sigma process excellence methods risk management (ISO 14971) 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.