Senior Quality Assurance Engineer

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 maintain 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 credentials (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:

• Bachelor's 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
• 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.