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.
Bonus or EquityThis position is also eligible for bonus as part of the total compensation package.
Pay RangeThe salary range for this position (in local currency) is 81,190.00 - 135,585.00
