Sr. Director of Quality

Nextek, Inc.•Madison, AL

19d

About The Position

Nextek, Inc. is a technology-driven Electronics Manufacturing Services company that provides precision electronic assembly and engineering services. The Senior Director of Quality & Compliance provides executive leadership for the company’s Quality Management System (QMS), product and manufacturing quality, regulatory compliance, customer and supplier quality, and continuous improvement programs. The position maintains and continually improves Nextek’s AS9100, ISO 9001, and ISO 13485 certification programs and ensures compliance with applicable customer, regulatory, contractual, and industry requirements. The role leads Quality activities across Nextek’s EMS operations, including SMT, through-hole assembly, soldering, inspection, test, conformal coating, rework and repair, box-build, and final inspection. It serves as Nextek’s senior Quality representative to executive management, customers, certification bodies, auditors, and suppliers, and has authority to stop production or shipment when product conformity, safety, customer requirements, or regulatory compliance are at risk. The Senior Director oversees the integrated QMS; quality operations and inspection; workmanship and certification programs; audits and corrective action; customer and supplier quality; aerospace, defense, and medical compliance; Management Review and quality performance; and the leadership and development of Quality personnel. The role also promotes a company-wide culture of quality, accountability, compliance, risk-based thinking, and continuous improvement.

Requirements

10+ years of progressive Quality management/leadership, Engineering, Manufacturing, or Compliance experience preferred.
Significant experience within EMS/electronics manufacturing and regulated industries.
Demonstrated experience managing multiple QMS certifications and customer/certification audits.
Strong working knowledge of AS9100, ISO 9001, ISO 13485, IPC-A-610, J-STD-001, IPC/WHMA-A-620, AS9102, CAR/CAPA, root-cause analysis, supplier quality, internal auditing, configuration management, calibration, risk management, and electronics manufacturing processes.

Nice To Haves

Bachelor’s degree in Engineering, Quality, Manufacturing, Industrial Management, Business, or a related technical discipline preferred; extensive directly applicable EMS and Quality leadership experience may be considered in combination with education.
Aerospace/Defense experience strongly preferred.
Medical Device manufacturing experience highly desirable.
Preferred certifications include ASQ CMQ/OE, CQE or CQA, AS9100/ISO Lead Auditor, IPC/J-STD certifications, and/or Lean Six Sigma certification.

Responsibilities

Provide executive ownership and direction for Nextek’s integrated QMS and maintain AS9100, ISO 9001, and ISO 13485 certification and compliance.
Monitor applicable regulatory, customer, contractual, and industry requirements and ensure effective implementation.
Lead certification, surveillance, recertification, customer, and regulatory audits; maintain audit readiness and improve the QMS.
Lead the Quality Laboratory and PCB/PCA, incoming, in-process, X-ray, final, and product-verification inspection activities.
Ensure effective quality controls throughout electronics manufacturing processes, including SMT, through-hole, soldering, cleaning, conformal coating, test, rework/repair, and box-build.
Ensure inspection personnel are appropriately trained, qualified, and certified.
Oversee workmanship and certification programs, including IPC-A-610, J-STD-001, applicable Space Addendum requirements, IPC/WHMA-A-620, IPC-7711/7721, and applicable customer and NASA requirements.
Ensure certifications remain current and that appropriate Class 1, 2, and 3 workmanship criteria are implemented as contractually required.
Manage risk-based internal and process audit programs and provide executive oversight of CAR/CAPA, customer and supplier corrective actions, audit findings, product escapes, and significant nonconformances.
Ensure effective root-cause analysis, corrective action, effectiveness verification, timely closure, and escalation of overdue or recurring issues.
Represent Quality in customer audits, quality reviews, corrective actions, and significant product-quality investigations; protect customer proprietary and confidential information.
Oversee supplier qualification, supplier audits, performance monitoring, incoming quality, SCARs, component traceability, and counterfeit-part prevention; partner with Supply Chain to improve supplier performance and reduce incoming defects.
Support applicable AS9102 First Article Inspection, configuration management, product safety, FOD prevention, traceability, counterfeit-part prevention, risk management, and customer quality-clause requirements.
Provide Quality oversight for ISO 13485 medical-device manufacturing, including applicable FDA requirements, customer Quality Agreements, traceability, manufacturing records, process validation, and risk-based controls.
Lead Quality inputs to Management Review and communicate significant quality risks, trends, resource needs, and improvement opportunities to executive management.
Establish and monitor quality KPIs, including First Pass Yield, DPMO, DPU, customer escapes and returns, CAR/CAPA performance, audit results, supplier quality, scrap/rework, Cost of Poor Quality, training/certification, and calibration compliance.
Drive measurable improvement in customer satisfaction, manufacturing quality, and QMS effectiveness.
Lead, mentor, and develop Quality personnel, including Quality Managers/Engineers, Supplier Quality, Quality Systems, Quality Laboratory personnel, PCB/PCA Inspectors, Quality Inspectors, and Internal Auditors.
Promote a company-wide culture of Quality, accountability, compliance, risk-based thinking, and continuous improvement.
Stop production or shipment when significant product-quality or compliance concerns exist; place material or product on Quality Hold and reject nonconforming product.
Require containment, additional inspection, investigation, and corrective action; escalate significant Quality and Compliance concerns directly to Executive Management.
Represent Nextek during customer and certification audits.