We are seeking a strategic and hands-on
Quality Leader to drive enterprise-wide quality excellence across complex manufacturing operations. This role is responsible for shaping quality strategy, leading continuous improvement initiatives, ensuring compliance with critical regulatory and industry standards, and building a culture of operational excellence.
The ideal leader brings a balance of executive-level strategic thinking and practical execution, with deep expertise in regulated manufacturing environments, supplier quality, process optimization, and cross-functional leadership. This is an opportunity to make a meaningful impact by elevating quality systems, improving throughput, reducing defects, and strengthening organizational performance across the business.
Key Responsibilities- Lead the overall quality function, including quality systems, compliance, reporting, and continuous improvement initiatives.
- Serve as the executive quality leader for ISO-certified quality management systems, including ISO 9001, ISO 13485, AS9100, and support environmental management initiatives aligned with ISO 14001.
- Act as Management Representative for applicable quality certifications, ensuring audit readiness and ongoing compliance.
- Drive enterprise quality planning for products, processes, and manufacturing operations.
- Chair Material Review Board (MRB) activities and oversee disposition of nonconforming materials.
- Establish and monitor quality KPIs, dashboards, and performance metrics to drive measurable improvement.
- Lead corrective and preventive action (CAPA) processes in partnership with Engineering, Manufacturing, and Operations.
- Partner with suppliers to strengthen supplier quality standards, compliance, and performance.
- Oversee calibration systems, preventive maintenance quality controls, and product/process quality assurance programs.
- Champion Lean, 6S, and operational excellence initiatives to improve quality, throughput, and efficiency.
- Develop and implement quality policies, procedures, and training programs to ensure consistent workmanship and adherence to standards.
- Promote awareness of customer, regulatory, and quality requirements throughout the organization.
- Ensure compliance with applicable regulatory frameworks including FDA, ITAR, IPC standards, and electronic manufacturing quality requirements.
- Lead, mentor, and develop quality teams while influencing cross-functional stakeholders at all levels.
Ideal Background- Bachelor's degree in Engineering, Quality, Manufacturing, or related technical discipline.
- 10+ years of progressive quality leadership experience in a regulated manufacturing environment.
- Deep experience with electronic manufacturing, aerospace, defense, medical device, or highly regulated production environments.
- Strong knowledge of:
- ISO 9001 / ISO 13485 / AS9100 / ISO 14001
- FDA quality and compliance requirements
- ITAR regulations
- IPC standards (including component identification, workmanship, inspection standards)
- CAPA, MRB, supplier quality, calibration systems, and process quality controls
- Lean Manufacturing / World Class Manufacturing / continuous improvement methodologies
- Proven ability to lead large teams and manage multiple technical initiatives simultaneously.
- Strong executive presence, communication skills, and the ability to influence across engineering, manufacturing, operations, and executive leadership.
- Strategic thinker with strong analytical problem-solving skills and a bias toward action.
- Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen.
