Quality Manager

Position Overview

PICA Manufacturing Solutions is seeking an experienced Quality Manager to lead and continuously improve our Quality Management System (QMS) across our global operations. This position is responsible for ensuring compliance with ISO 9001, ISO 13485, AS9100, and ITAR requirements while driving operational excellence through supplier quality, manufacturing quality, customer quality, and continuous improvement initiatives.

The Quality Manager serves as the company's quality leader, working closely with executive leadership, engineering, manufacturing, supply partners, and customers to ensure products consistently meet customer, regulatory, and company requirements. This individual will play a critical role in supporting new product introductions, improving manufacturing processes, reducing defects, and strengthening supplier performance throughout PICA's global supply chain.

This position requires a hands-on leader who is equally comfortable developing quality strategies, leading audits, solving complex technical problems, and working directly with customers and suppliers

Responsibilities Include:
Quality Management System

• Serve as the Management Representative for PICA Manufacturing Solutions' ISO 9001 and ISO 13485 Quality Management Systems.
• Maintain and continuously improve the Quality Management System.
• Ensure compliance with applicable statutory, regulatory, customer, and industry requirements.
• Develop, maintain, and improve company operating procedures, work instructions, forms, and quality documentation.
• Maintain the document control system.
• Lead Management Review meetings and report quality performance to executive leadership.
• Develop and monitor company Quality Objectives and Key Performance Indicators (KPIs).

Manufacturing Quality

• Oversee incoming inspection, in-process inspection, final inspection, and product release activities.
• Ensure manufacturing processes consistently meet customer and quality requirements.
• Lead product and process improvement initiatives utilizing Lean Manufacturing and Six Sigma methodologies.
• Partner with Manufacturing and Engineering to reduce defects, improve yields, and increase process capability.
• Support New Product Introduction (NPI) activities to ensure products transition successfully into production.

Customer Quality

• Serve as the primary customer contact for all quality-related matters.
• Lead customer complaint investigations and ensure timely resolution.
• Oversee Corrective Action Requests (CARs), Non-Conforming Material Reports (NCMRs), Root Cause Analysis, and CAPA activities.
• Participate in customer audits and quality reviews.
• Monitor customer quality performance metrics and develop improvement plans.

Continuous Improvement

• Lead cross-functional continuous improvement initiatives.
• Utilize structured problem-solving methodologies including:
  • 8D
  • 5 Why
  • Fishbone (Ishikawa)
  • FMEA
  • SPC
  • GR&R
  • Process Capability (Cp/Cpk)
  • DOE
  • Statistical Analysis
• Develop and maintain company quality dashboards and metrics.
• Identify opportunities to improve product quality, manufacturing efficiency, supplier performance, and customer satisfaction.

Leadership

• Lead, mentor, and develop Quality personnel.
• Establish departmental goals and performance expectations.
• Foster a culture of continuous improvement throughout the organization.
• Work collaboratively across Engineering, Manufacturing, Supply Chain, Program Management, and Executive Leadership.

Qualifications
Required

• Minimum 5 years of Quality Engineering or Quality Management experience within an Electronics Manufacturing Services (EMS) or Printed Circuit Board Assembly (PCBA) environment.
• Minimum 2 years of leadership or supervisory experience.
• Strong working knowledge of ISO 9001 Quality Management Systems.
• Experience leading internal and external quality audits.
• Experience with supplier quality management and supplier development.
• Experience conducting root cause analysis and corrective action investigations.
• Strong technical understanding of PCB fabrication, SMT assembly, electromechanical assembly, and manufacturing processes.
• Excellent verbal, written, and presentation skills.
• Ability to communicate effectively with customers, suppliers, and international manufacturing partners.
• Strong analytical and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment

Preferred

• Bachelor's Degree in Engineering, Quality, Manufacturing, or related discipline.
• ISO 13485 experience.
• Certified Lead Auditor (ISO 9001 and/or ISO 13485).
• ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification.
• Six Sigma Green Belt or Black Belt.
• Experience with PPAP, APQP, FAIR, Control Plans, PFMEA, and Validation activities.
• Knowledge of IPC-A-610, IPC J-STD-001, IPC-7711/7721, and IPC standards.
• Experience with ERP/MRP systems and quality reporting software.
• Experience using statistical software such as Minitab.

Knowledge & Skills

• ISO 9001, ISO 13485, AS 9100, & ITAR Quality Management Systems
• Supplier Quality Management
• Customer Quality Management
• Corrective and Preventive Actions (CAPA)
• Internal & Supplier Auditing
• Risk Management
• Statistical Process Control (SPC)
• Lean Manufacturing
• Six Sigma
• Root Cause Analysis
• Process Validation
• Document Control
• Process Capability (Cp/Cpk)
• Team Leadership
• Continuous Improvement
• Strong technical writing skills
• Excellent communication and presentation skills

Travel

• Ability and willingness to travel approximately 15-25% , including domestic and international travel, to support supplier audits, customer meetings, new product introductions, and global manufacturing operations

Benefits

• Competitive Salary (commensurate with experience)
• Comprehensive Medical, Dental & Vision Insurance
• Company Paid Life Insurance
• Flexible Paid Time Off (PTO)
• 401(k) with Company Match
• Profit Sharing Program
• Annual Performance Bonus
• Professional Development & Training Opportunities
• Flexible Remote Work (when business needs allow)