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Job Summary: The Senior Quality Assurance Engineer will join our team in Wroclaw, Poland, and lead quality execution and continual improvement initiatives across the product lifecycle from concept and design through New Product Introduction (NPI) and sustaining. This role is responsible for embedding robust design quality practices (Commodity Specific Design Rule Implementation, Design for Quality Assessments, Risk Management, Verification, and Validation test planning, etc.), ensuring flawless NPI launches, and maintaining world‑class product field performance. 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 credential (IRCA / Exemplar Global, etc.).

Key Responsibilities

• Design & Development Quality
  • Develop, review, and improve product lifecycle quality plans.
  • Own and drive Design for Quality (DfQ), Design Failure Modes and Effects Analysis (DfMEA), and design control deliverables, ensuring traceability from requirements to verification / validation.
  • Champion risk management throughout the lifecycle owning control plans and maintaining risk files.
  • Lead technical design reviews with a focus on Design for Quality during concept design through detailed design to ensure validation readiness, ensuring that the product design functions as intended in the end‑use environment.
  • Define acceptance criteria, measurement systems (MSA, GR&R), and Critical to Quality (CtQ) characteristics.
  • Partner with Design Engineering, Product Management, and Operations on design specifications and tolerances, as well as manufacturability.
• New Product Introduction (NPI)
  • Plan and execute APQP (or equivalent) including control plans, Process Failure Modes and Effects Analysis (PFMEA), PPAP, and process capability analysis / rolled throughput yield (RTY).
  • Support Supplier Quality initiatives, as applicable, to support supplier and component qualifications (incoming quality plans, first article inspection reports, sampling strategies, etc.).
  • Define and release robust process controls for launch to secure production readiness from a product quality perspective.
  • Own NPI Quality metrics, including but not limited to launch DPPM, customer escapes, etc.
• Sustaining
  • Lead structured problem solving (8D / Ishikawa / 5‑why) as part of the Fortive Problem Solving Process (PSP) for root cause analysis and corrective action to prevent recurrence of issues.
  • Monitor product health (returns, complaints, warranty, reliability, etc.) and own problem solving to drive continual improvement in reduction of field failures and complaints.
  • Optimize in‑process and end‑of‑line inspection and testing strategies.
  • Identify, measure, monitor, and improve product rework and scrap that contributes to Cost of Poor Quality (CoPQ).
  • Collaborate with Service and/or Customer Service on field issue containment and communication.
• Quality Management System (QMS), Auditing, and Compliance
  • Serve as lead auditor for ISO 9001:2015 in planning, executing, and reporting internal audits while supporting external audits (3rd party certification & surveillance, 2nd party customer audits).
  • Ensure procedures, work instructions, and records meet QMS requirements.
  • Support Supplier Audits and development, including verification of effectiveness of closure on nonconformities.
  • Promote a culture of quality, data integrity, and continual improvement leveraging the Fortive Business System (FBS).

Required Qualifications

• Bachelors degree in engineering (Mechanical, Electrical, Manufacturing, Materials).
• 5‑8 years of experience in Quality Engineering, including hardware and software, and system‑level products, with end‑to‑end lifecycle exposure (design → NPI → sustaining).
• ISO 9001:2015 Certified Lead Auditor via IRCA / Exemplar Global or recognized equivalent.
• ASQ Certified Quality Engineer or equivalent.

Desired Skills

• Demonstrated knowledge and effective use of quality tools and methodologies for DFMEA, PFMEA, problem solving (8D, Ishikawa), lean and six sigma methodologies, APQP/PPAP, MSA/GR&R, control plans, capability analysis / RTY.
• Experience with additional standards (ISO 13485).
• Familiarity with Oracle PLM, MES, ERP.
• Familiarity with Reliability Engineering concepts and methods (Weibull analysis, FRACAS).
• Systems thinking and lifecycle quality planning.
• Data‑driven decision maker with statistical rigor.
• Risk based, process approach and audit discipline.
• Influencing without authority; constructive challenge.
• Ownership, urgency, and continual improvement mindset.

Fortive Corporation Overview

Fortive’s essential technology makes the world safer and more productive. 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. We are a diverse team 10,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

About Fluke

Fluke is leading the world in creating software, test tools and technology that will support customers today and in the future. We are a customer‑obsessed market leader with a strong reputation for reliability, quality and safety. A wholly owned subsidiary of Fortive Corporation (www.fortive.com), Fluke is a global corporation headquartered in the greater Seattle area. Driven by the successful Fortive Business System, Fluke offers the passion of a startup with the resources of a Fortune 500 company. We are focused on the growth of our individual employees, teams and the Fluke brand.

E‑EO Statement

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal‑opportunity employers. 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, please contact us at applyassistance@fortive.com.

Seniority level

Not Applicable

Employment type

Full‑time

Job function

Engineering and Information Technology

Industries

Appliances, Electrical, and Electronics Manufacturing