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/Responsibilities Senior 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.
Quality Operations & Inspection - 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.
IPC/J-STD Programs - 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.
Audits & Corrective Action - 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.
Customer & Supplier Quality - 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.
Aerospace/Defense & Medical Compliance - 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.
Management Review & Quality Performance - 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 quality, scrap/rework, Cost of Poor Quality, training/certification, and calibration compliance.
- Drive measurable improvement in customer satisfaction, manufacturing quality, and QMS effectiveness.
Leadership Responsibilities Provide leadership, mentoring, and development for 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. Education - Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Management, Business, or related technical discipline preferred.
- Extensive directly applicable EMS and Quality leadership experience may be considered in combination with education.
Experience - 10+ years of progressive Quality management/leadership, Engineering, Manufacturing, or Compliance experience preferred.
- Significant experience within EMS/electronics manufacturing and regulated industries.
- Aerospace/Defense experience strongly preferred; Medical Device manufacturing experience highly desirable.
- Demonstrated experience managing multiple QMS certifications and customer/certification audits.
Technical Knowledge
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. Preferred certifications include ASQ CMQ/OE, CQE or CQA, AS9100/ISO Lead Auditor, IPC/J-STD certifications, and/or Lean Six Sigma certification. Position Authority The Senior Director of Quality & Compliance has authority to: - Stop production or shipment when significant product-quality or compliance concerns exist.
- Place material/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.
Benefits
Medical/Dental/Vision insurance
Life Insurance
Short/Long term disability
Critical Illness Insurance
Accident Insurance
Paid Time Off
10 Paid Holidays
401k Match
Employee Assistance Plan (EAP)
Educational Reimbursement EEO Employer: Nextek, Inc. is committed to being an Equal Opportunity Employer. All employment decisions are made without considering race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic information, military/veteran status, or any other characteristic protected by law.
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