Senior Quality Engineer (Product & Customer Quality)

Job Summary

Lead quality assurance and customer quality activities to ensure products, processes, and systems consistently meet customer, regulatory, and organizational requirements. Drive continuous improvement initiatives, manage complex quality issues, lead cross-functional problem-solving teams, and serve as the key quality representative for customers, suppliers, and internal stakeholders.

Key Responsibilities

Quality Management System

Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 9001, ISO 13485 (where applicable), customer-specific requirements, and applicable regulatory standards.

Drive quality system effectiveness through audit readiness, compliance monitoring, and continuous process improvement initiatives.

Provide guidance and mentorship to engineers, technicians, and functional teams on quality requirements and best practices.

Customer Quality Management

Act as the primary quality interface for assigned customers and lead customer quality reviews, issue resolution, and performance improvement activities.

Manage customer complaints, quality escalations, and customer scorecard performance.

Lead customer audits and coordinate responses for audit findings and corrective actions.

Problem Solving & CAPA

Lead complex investigations using structured problem-solving methodologies such as 8D, 5 Why, Fishbone, DMAIC, and Fault Tree Analysis.

Drive CAPA activities and ensure timely implementation, effectiveness verification, and sustainable closure.

Analyze quality trends and data to identify systemic issues and preventive improvement opportunities.

Product and Process Quality

Lead NPI, technology transfer, process validation, qualification, and manufacturing readiness activities.

Review and approve PFMEA, Control Plans, Process Flow Diagrams, Work Instructions, FAI, PPAP, and validation documentation.

Ensure effective control of non-conforming products, deviation management, and change control processes.

Supplier Quality Support

Collaborate with Supplier Quality teams to address supplier performance issues and drive corrective actions.

Support supplier audits, qualification activities, and supplier quality improvement programs.

Metrics & Continuous Improvement

Monitor and analyze key quality indicators including:

• Customer PPM
• Internal PPM
• First Pass Yield (FPY)
• Scrap Rate
• Cost of Poor Quality (COPQ)
• Customer Complaints
• Audit Findings
• CAPA Effectiveness

Lead Lean Six Sigma and operational excellence initiatives to improve product quality, process capability, and manufacturing efficiency.

Risk Management

Facilitate risk management activities including PFMEA reviews, process risk assessments, and mitigation plans.

Ensure risks impacting product quality, compliance, and customer satisfaction are proactively identified and addressed.

Leadership & Collaboration

Lead cross-functional teams involving Manufacturing, Engineering, Operations, Supply Chain, and Customers to resolve quality issues.

Provide technical leadership, coaching, and support to junior engineers and quality personnel.

Present quality performance, risks, and improvement initiatives to management and customers.

Qualifications

• Bachelor's Degree in Engineering, Manufacturing, Quality, Electronics, Mechanical Engineering, or related discipline.
• Minimum 5-8 years of experience in Quality Engineering within Electronics Manufacturing, Medical Device, Semiconductor, Automotive, Aerospace, or other regulated industries.
• Demonstrated experience leading customer-facing quality activities and complex problem-solving initiatives.
• Strong knowledge of quality management systems, regulatory requirements, and manufacturing processes.

Technical Competencies

• ISO 9001
• ISO 13485 (preferred)
• Customer-Specific Quality Requirements
• PFMEA & Control Plans
• APQP & PPAP
• CAPA & 8D Methodology
• SPC & Statistical Analysis
• MSA & Gage R&R
• Process Validation & Qualification
• Root Cause Analysis
• Risk Management
• Audit Management
• NPI & Product Transfer
• Lean Manufacturing & Six Sigma
• Minitab and Quality Analytics Tools

Preferred Qualifications

• Certified Quality Engineer (CQE)
• Six Sigma Green Belt or Black Belt
• Lead Auditor Certification
• Experience in PCBA, SMT, Box Build, or Medical Device Manufacturing
• Knowledge of FDA QSR/QMSR, ISO 14971, or MDSAP (where applicable)
• Experience with electronic Quality Management Systems (eQMS)

Key Performance Indicators (KPIs)

• Customer Complaint Reduction
• Customer PPM Achievement
• CAPA Closure and Effectiveness
• Audit Compliance Score
• Supplier Quality Performance
• FPY Improvement
• COPQ Reduction
• NPI Quality Readiness
• Customer Satisfaction Metrics
• On-Time Closure of Quality Actions