Sr. Director of Quality
Listed on 2026-10-24
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Position: Sr. Director of Quality
Location: Madison, AL
Job : 40-2026-13
# of Openings: 1
Nextek, Inc. is a niche market, technology-driven Electronics Manufacturing Services (EMS) company, founded in 1995. We offer precision electronic assembly and engineering services to customers with needs-driven, non-commodity products. We partner with companies who have unique product needs and who seek a high level of reliability, commitment, and professional service from their manufacturing partners.
Duties/ResponsibilitiesSenior Director of Quality & Compliance provides executive leadership for the company's Quality Management System (QMS), product and manufacturing quality, regulatory compliance, customer quality, supplier quality, and continuous improvement programs.
This position is responsible for maintaining and continually improving Nextek's AS9100, ISO 9001, and ISO 13485 certification programs and ensuring compliance with applicable customer, regulatory, contractual, and industry requirements.
The Senior Director will lead Quality activities supporting Nextek's Electronics Manufacturing Services operations, including SMT, through-hole assembly, soldering, inspection, test, conformal coating, rework/repair, box-build, and final inspection.
The position serves as Nextek's senior Quality representative to executive management, customers, certification bodies, auditors, and suppliers. It has authority to stop production or shipment when product conformity, safety, customer requirements, or regulatory compliance are at risk.
Quality Management System & Compliance- Provide executive ownership and direction for Nextek's integrated QMS.
- Maintain certification and compliance with AS9100, ISO 9001, and ISO 13485.
- Monitor applicable regulatory, customer, contractual, and industry requirements and ensure effective implementation.
- Lead certification, surveillance, recertification, customer, and regulatory audits.
- Maintain organizational audit readiness and drive continual QMS improvement.
- Provide leadership for the Quality Laboratory, PCB/PCA inspection, incoming inspection, in-process inspection, X-ray, final inspection, and product verification activities.
- Ensure effective quality controls throughout SMT, through-hole, wave/selective solder, hand soldering, cleaning, conformal coating, test, rework/repair, and box-build operations.
- Ensure inspection personnel are appropriately trained, qualified, and certified.
- Provide oversight of 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/NASA workmanship requirements.
- Ensure certifications remain current and appropriate Class 1, 2, and 3 artistry criteria are implemented as contractually required.
- Manage Nextek's risk-based Internal Audit and Process Audit programs.
- Provide executive oversight of CAR/CAPA, customer corrective actions, 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.
- Serve as the senior Quality representative during 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 KPIs including First Pass Yield, DPMO, DPU, customer escapes/returns, CAR/CAPA performance, audit results, supplier…
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