Sustaining Quality Lead: Medical Devices & CI

Orion Global Talent; Town of Vermont (WI); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Work-life balance

Job summary

Orion Global Talent seeks a Sustaining Quality Manager for a Vermont medical device manufacturing facility. This role leads quality engineering, CAPA, nonconformance reduction, and regulatory compliance to ensure products meet ISO 13485, FDA, GMP standards.

You will mentor Sustaining Quality Engineers and collaborate with Operations, Regulatory Affairs, and suppliers to drive continuous improvement, improve yield, and deliver customer satisfaction in a highly regulated environment.

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, Life Sciences or related field.
• 7+ years of Quality Engineering or Quality Management in regulated manufacturing.
• 3+ years of leadership experience.
• Strong knowledge of ISO 13485, FDA requirements, CAPA, QMS, SPC, FMEA, MSA/Gage R&R.
• Experience with medical devices or highly regulated manufacturing.

Responsibilities

• Lead and mentor Sustaining Quality Engineers and Quality Technicians.
• Ensure compliance with ISO 13485, FDA, GMP, QMS, and customer requirements.
• Manage quality performance for existing production programs.
• Lead CAPA, nonconformance, customer complaint, and root cause investigations.
• Apply problem-solving methodologies including 5 Why, Fishbone, and DMAIC.
• Monitor and improve yield, scrap, PPM, COPQ, process capability, and customer quality metrics.
• Lead continuous improvement initiatives to reduce defects and improve process stability.
• Support IQ/OQ/PQ process validation and revalidation.
• Review engineering changes, process modifications, risk assessments, and change controls.
• Serve as a key quality contact for customers and lead quality reviews and issue resolution.
• Support internal, customer, supplier, and regulatory audits.
• Partner with Supplier Quality and Purchasing on supplier performance and corrective actions.
• Develop and present quality KPIs and performance metrics to site leadership.
• Promote a strong culture of quality ownership and continuous improvement.

Skills

Quality Engineering

Leadership

Regulatory compliance

CAPA

Root cause analysis

Process validation

Quality metrics

Education

Bachelor's degree in Engineering/Quality/Manufacturing/Life Sciences

Tools

QMS

SPC

FMEA

MSA/Gage R&R

Job description

Orion Global Talent seeks a Sustaining Quality Manager for a Vermont medical device manufacturing facility. This role leads quality engineering, CAPA, nonconformance reduction, and regulatory compliance to ensure products meet ISO 13485, FDA, GMP standards.

You will mentor Sustaining Quality Engineers and collaborate with Operations, Regulatory Affairs, and suppliers to drive continuous improvement, improve yield, and deliver customer satisfaction in a highly regulated environment.