Quality Director

The Quality Director is responsible for leading all aspects of the company’s quality management program, including inspection, testing, quality assurance, and continuous improvement over 3 manufacturing sites. This is a hands-on leadership position that requires both strategic oversight and direct involvement in inspection and problem-solving activities on the production floor. The Quality Director ensures that products consistently meet customer requirements, internal standards, and applicable regulatory and industry certifications.

Key Responsibilities:

· Champion and uphold the company’s values, vision, mission and quality policy in all activities.

· Adhere to and help enforce company policies, procedures, and internal control standards.

· Direct and manage all activities within the Quality Department, including Quality Engineers, Inspectors, and Technicians.

· Establish department goals, KPIs, and quality objectives that align with company strategy.

· Develop, coach, and evaluate team members to ensure competence, engagement, and accountability. Lead by example, maintaining a visible and active presence on the production floor.

· Oversee and participate in first article, in-process, and final inspections to verify compliance with specifications and drawings.

· Interpret engineering drawings and specifications, including GD&T.

· Use precision measurement tools (calipers, micrometers, indicators, CMMs, gauges, etc.) to verify part conformance.

· Develop, maintain, and continuously improve inspection plans, work instructions, and sampling procedures.

· Maintain calibration and control of all inspection equipment.

· Manage and maintain the company’s QMS in compliance with ISO9001:2015, ISO 13485:2016 and AS9100D (and/or industry-specific standards).

· Lead internal and external audits, ensuring audit findings are documented, corrected, and closed on time.

· Oversee documentation control, ensuring policies, procedures, and records are current and accurate.

· Prepare and submit quality reports and performance metrics to senior leadership.

· Lead root cause analysis and corrective/preventive actions (CAPA) for nonconformances and customer issues.

· Collaborate with production, engineering, and supply chain teams to resolve quality issues and prevent recurrence.

· Drive initiatives to reduce scrap, rework, and process variation.

· Utilize Lean, Six Sigma, or other quality tools to identify and implement process improvements.

· Serve as the primary point of contact for customer quality concerns, audits, and certifications.

· Investigate and resolve customer complaints with professionalism and urgency.

· Manage supplier quality performance and assist with incoming inspection or supplier corrective actions as needed.

· Collect, analyze, and report key quality performance indicators (defect rates, rework, scrap, returns, etc.).

· Use data to identify trends, recommend improvements, and support operational decision-making.

Qualifications:

· Bachelor’s degree in Engineering, Quality Management, or related technical discipline; equivalent experience considered.

· Minimum 7 years of progressive quality experience in a manufacturing environment, including at least 3 years in a leadership role.

· Strong hands-on inspection skills and understanding of dimensional measurement tools and techniques.

· Proven ability to read and interpret complex blueprints and apply GD&T principles.

· In-depth knowledge of ISO9001:2015, ISO 13485:2016 and AS9100D and quality management systems.

· Experience with corrective actions, root cause analysis, and continuous improvement methodologies.

· Excellent leadership, communication, and team-building skills.

· Proficiency in Microsoft Office and quality software systems (SPC, CMM, or QMS software).

· Demonstrated ability to interact effectively with customers, suppliers, and all levels of internal personnel.

· Experience in plastics, precision machining, or manufacturing for regulated industries.

· Experience with PPAP, FMEA, control plans and other advanced quality planning tools.

Work Environment:

· Work environment includes manufacturing and warehouse settings with exposure to machinery, moderate noise and variable temperatures.

· Must be able to stand and move between production and office areas frequently.

· Hands-on leadership expected.

· May involve standing for long periods, lifting up to 50 lbs, and working near machinery.

Expected Hours of Work:

· This is a full-time position, typically Monday through Friday. While weekend work is rare, occasional weekend activity may be required based on business needs.

Travel:

· 10%

· Possible international travel