Quality Director

Overview

For over 35 years, OSI Electronics has provided Manufacturing Solutions of the highest quality,

reliability,and customer support. We specialize in customized Manufacturing Solutions with the portfolio

of services,capabilities, and factory locations needed to provide our customers with a competitive

advantage in theglobal marketplace.

OSI Electronics offers turnkey solutions for the full range of assembly complexity. We partner with

Customers on Product Development, New Product Introduction, Mass Production, Sustaining

Engineeringand Product Lifecycle Management. Our cutting edge technology, manufacturing proficiency

and responsivetechnical services deliver the Tier One capabilities Customers require

Responsibilities

Role :

The Director of Quality is responsible for leading the overall Quality Management System (QMS) strategy, execution, and continuous improvement for a multi-site electronics manufacturing operation specializing in PCBA, cable/harness, and system integration. This role ensures compliance with applicable industry standards, regulatory requirements, and customer expectations while driving a culture of quality, operational excellence, and risk-based thinking.

This position serves as a key member of leadership, responsible for aligning quality performance with business objectives and customer satisfaction.

Responsibilities

• Quality Strategy & Leadership
• Implement the company's quality vision, strategy, and objectives aligned with business goals.
• Drive a quality-first culture emphasizing accountability, continuous improvement, and customer focus.
• Provide leadership and direction across all quality functions (QA, QE, Supplier Quality, Compliance).
• Quality Management System (QMS) Oversight
• Ensure establishment, implementation, and maintenance of a compliant and effective QMS across all APAC sites.
• Ensure compliance to:
• ISO 9001
• ISO 13485 (medical)
• AS9100 (aerospace)
• IATF 16949 (as applicable)
• Ensure QMS processes align with regulatory requirements and customer specifications.
• Drive standardization and harmonization of quality processes across sites.
• Customer & Regulatory Interface
• Serve as primary quality interface with key customers , regulatory bodies, and certification agencies.
• Lead resolution of customer complaints, RMAs, and escalations.
• Ensure effective corrective and preventive action (CAPA) systems.
• Support customer audits and regulatory inspections.
• Operational Quality & Manufacturing Excellence
• Oversee quality assurance activities for PCBA manufacturing, cable/wire harness, and box build operations.
• Ensure robust controls for:
• Incoming inspection and supplier quality
• In-process quality (AOI, ICT, functional test)
• Final inspection and test release
• Drive deployment of Lean, Six Sigma, SPC, and risk-based quality methodologies.
• Ensure product conformity, traceability, and reliability performance.
• Supplier Quality & Risk Management
• Lead supplier quality management including qualification, monitoring, and development.
• Ensure strong supplier oversight including sub-tier control and counterfeit prevention.
• Implement robust supplier performance metrics and corrective actions.
• Audit, Compliance & Certification
• Lead internal and external audit programs, including certification and surveillance audits.
• Ensure audit readiness and effective closure of nonconformances.
• Maintain compliance with regulatory frameworks (e.g., FDA QMSR alignment to ISO 13485).
• Data & Performance Management
• Define and track key quality metrics (KPIs), including:
• Yield, DPPM, COPQ
• Customer Quality
• Customer On-Time Delivery
• Supplier performance (On-Time Delivery and Quality)
• Analyze quality data and drive executive-level reporting and decision-making.
• Continuous Improvement & Innovation
• Lead enterprise-level continuous improvement initiatives.
• Drive root cause analysis (8D, RCA, Six Sigma).
• Promote predictive, data-driven quality systems and digital transformation (e.g., real-time SPC).
• Organizational Leadership
• Build and develop a high-performing quality organization.
• Define roles, responsibilities, and authority for all quality personnel.
• Collaborate cross-functionally (Engineering, Operations, Supply Chain, Program Management).
  

Competency

• Strategic leadership and executive communication
• Strong analytical and problem-solving skills
• Expertise in Lean, Six Sigma, and statistical tools
• Customer-focused mindset
• Risk-based thinking and decision-making
• Understands the technical elements of the business and will be a front-line participant in all quality issues
• Extensive experience in operations issues and excellent communication skills.
  
  

Key Performance Indicators (KPIs)

• Customer quality performance (PPM, complaints, escapes)
• First pass yield / scrap / rework reduction
• Audit results (internal, external, certification)
• Supplier quality performance
• CAPA effectiveness and closure timeliness
• Cost of Poor Quality (COPQ) reduction
  
  

Work Environment

• Multi-site manufacturing environment (domestic and/or international)
• Frequent interaction with customers, suppliers, and regulatory bodies
• Possible travel (20–30%)
  
  

Qualifications

• Bachelor's degree in Engineering, Quality, or related field (Master's/MBA preferred).
• 12–15+ years of quality experience in electronics manufacturing (PCBA, EMS).
• 5–10+ years in leadership roles overseeing multi-site operations.
  
  

Technical & Regulatory Expertise

• Strong knowledge of:
• PCBA manufacturing processes and controls
• IPC standards (IPC-A-610, J-STD-001, IPC-7711/21, etc.)
• ISO 9001, ISO 13485, AS9100, IATF 16949
• Experience with:
• QMS implementation and audits
• CAPA systems and regulatory complianc
• Supplier quality management