Hands-On Quality Leader | ISO 13485 & CAPA Champion

Piezo Technologies; Indianapolis (IN); On-site; USD 120,000 - 160,000; Full time

Job summary

Piezo Technologies, located in Indiana, seeks a seasoned Quality Manager to lead the QMS, ensure regulatory compliance, and drive operational excellence in a hands-on leadership role on the manufacturing floor.

You will lead investigations, CAPA, and continuous improvement programs with Operations, Engineering, and Supply Chain, delivering measurable quality results and customer satisfaction.

Qualifications

• Minimum of 10 years of progressive quality experience in a regulated manufacturing environment (medical device preferred).
• Minimum of 5 years of leadership experience in a Quality Manager or equivalent role.
• Demonstrated success leading ISO 13485-compliant QMS and driving improvements in quality, compliance, and operational performance.
• Experience leading customer, regulatory, and certification audits; CAPA; root cause investigations; and continuous improvement initiatives.
• Lean Manufacturing and Six Sigma experience; Six Sigma Green Belt or higher preferred.
• This position requires ITAR compliance; US person or protected individual required.

Responsibilities

• Lead and continuously improve the Quality Management System (QMS) to meet customer, regulatory, and business requirements.
• Serve as Management Representative for ISO 13485 and other applicable QMS.
• Drive process discipline to build quality into manufacturing processes, not just inspect it.
• Spend significant time on the manufacturing floor coaching employees and driving corrective actions.
• Lead investigations involving customer complaints, escapes, and significant quality events.
• Oversee CAPA, root cause analysis, PFMEA, SPC, and statistical methods for continuous improvement.

Skills

Quality leadership

Regulatory compliance

Root cause analysis

Data-driven decision making

Cross-functional leadership

Problem solving

Education

Bachelor's degree in Engineering/Quality Management

ASQ CMQ/OE or CQE or CQA or Six Sigma certification

Job description

Piezo Technologies, located in Indiana, seeks a seasoned Quality Manager to lead the QMS, ensure regulatory compliance, and drive operational excellence in a hands-on leadership role on the manufacturing floor.

You will lead investigations, CAPA, and continuous improvement programs with Operations, Engineering, and Supply Chain, delivering measurable quality results and customer satisfaction.