Senior Quality Engineer
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Job Location:
Everett, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
Job Summary:
As a Senior Quality Engineer at Fluke you will play a critical role in ensuring the quality reliability and safety of Fluke products across the entire product lifecycle.
This position demands strong analytical capability technical depth in electronics and mechanical systems disciplined problem solving and the ability to influence teams without authority.
You will drive robust quality planning verification and validation rigor risk mitigation and continual improvement initiatives. You will ensure that Fluke products meet customer expectations comply with regulatory and industry standards and deliver worldclass performance in the field.
The ideal candidate will have hands on experience in representing Product Quality in Engineering Design Reviews Product Part Approval Process (PPAP) / Advanced Product Quality Planning (APQP) (or equivalent) problem solving and a 3rd party ISO 9001:2015 Lead Auditor credentials.
This is an onsite inperson role based at our Fluke Everett location.
Key Responsibilities:
Design & Development Quality
- Lead development review and execution of product lifecycle quality plans from concept through launch.
- Own and drive Design for Quality (DfQ) DFMEA design control deliverables ensuring traceability from requirements to verification / validation.
- Champion risk management throughout the lifecycle owning control plans and maintaining risk files.
- Define acceptance criteria test strategies measurement system analyses (MSA/GR&R) and CriticaltoQuality (CtQ) parameters.
- Partner with Design Engineering Product Management and Operations on design specifications manufacturability reliability and risk.
- Plan and execute APQP (or equivalent) including PFMEA control plans PPAP and process capability analysis / rolled throughput yield (RTY) and production readiness assessments.
- Validate production test systems calibration methods and in-process inspection strategies.
- Ensure smooth transition from development to production through crossfunctional reviews and readiness gates.
- Track and own launch quality metrics (DPPM escapes warranty early life failures).
- Monitor product health (returns complaints yields warranty reliability etc.) and own problem solving to drive continual improvement.
- Identify measure monitor and improve product rework and scrap that contributes to Cost of Poor Quality (CoPQ).
- Lead rootcause investigations using 8D 5Whys Ishikawa and statistical methods.
- Lead stop ship containment investigations communications and other quality-related activities.
- Optimize in-process and end of line inspection and testing strategies and reduce variation.
New Product Introduction (NPI)
Sustaining Quality
- Support change control evaluations (ECOs process changes component changes) to ensure continued product quality.
- Collaborate with Service and Customer Support on customer issues containment corrective actions and communication.
- Lead crossfunctional quality reviews and drive consensus on qualitycritical decisions.
- Communicate risks issues and performance trends to leadership with clarity and datadriven insights.
- Serve as lead auditor for ISO 9001:2015 in planning executing and reporting internal audits while supporting external audits.
- Ensure quality procedures work instructions and records meet QMS requirements.
- Support supplier and customer audits including verification of effectiveness of closure on nonconformities.
- Promote a culture of quality data integrity and continual improvement leveraging the Fortive Business System (FBS).
Quality Systems Compliance & Auditing
Required Qualifications
- Bachelors degree in Electrical Manufacturing Systems or related engineering discipline.
- 8-10 years of Quality Engineering experience across hardware electromechanical or embedded system products.
- Strong knowledge of V&V methodologies statistical tools and quality engineering principles.
- Experience with DFMEA PFMEA MSA GR&R control plans and structured problem solving.
- Internal auditor or lead auditor certification preferred.
- Handson experience with failure analysis and reliability concepts.
- Proficiency with data analysis tools (Minitab Power BI or similar).
- Experience in Lean Kaizen or Six Sigma (Green Belt or higher).
- ASQ Certified Quality Engineer or equivalent.
- Knowledge of ISO 9001/ 13485 ISO/IEC 17025 or similar standards.
Desired Skills
- Experience with PCBA processes electronics manufacturing or test system development.
- Familiarity with PLM ERP MES or digital quality systems.
- Familiarity with Reliability Engineering concepts and methods (Weibull analysis FRACAS).
- Ability to influence without authority and deliver results in a fastpaced environment.
- High sense of ownership urgency and continuous improvement mindset.
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Fortive Corporation Overview Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product d ... View more
