Job Title: Quality Manager
Holyoke, MA, US, 01040
Paragon Medical is a leading partner in medical device manufacturing, providing comprehensive supply chain solutions from concept to delivery. With expertise in implants, surgical instrumentation, and disposable devices, we offer tailored solutions to exceed customer expectations.
Job Summary: Responsible for ensuring the production of high-quality medical devices, from order receipt to shipment and documentation. Develops and implements internal systems to meet customer, ISO 13485, and FDA 820/GMP requirements.
Key Responsibilities:
- Build, manage, and lead a team of technical quality associates.
- Develop training programs and provide instruction on quality and process tools.
- Support the development and maintenance of a quality system meeting ISO and FDA requirements.
- Drive continuous improvement initiatives through data analysis and corrective action implementation.
- Supervise quality engineers and inspection processes.
- Ensure compliance with FDA and customer guidelines.
- Participate in internal and external audits.
- Lead Six Sigma and lean manufacturing projects.
- Provide budget inputs and track costs.
- Review and implement corrective actions based on customer performance metrics.
- Maintain validated processes and oversee calibration of monitoring devices.
- Develop product-specific Inspection and Control Plans.
- Lead project implementations for Process Flow, Quality Systems, and Statistical Process Controls.
- Work directly with customers on Dock to Stock programs.
- Manage factory metric boards and Quality Council.
- Develop and implement actions to meet corporate Quality and Delivery objectives.
- Manage the calibration process.
- Provide occasional production assistance and technical guidance.
- Participate in external audits and regulatory affairs.
Education and Experience:
- Minimum Bachelor's Degree, preferably in mathematics, statistics, or industrial practices.
- 7+ years of equivalent Quality Management or Quality Engineering experience. ASQC certifications may be considered in lieu of a degree.
Knowledge, Skills, and Abilities (KSA's):
- Excellent interpersonal and communication skills.
- Proficiency in statistical process control techniques.
- Self-motivated and able to work with minimal supervision.
Physical Demands:
- Sitting, standing, walking, grasping, climbing, stooping, kneeling, or crawling as required.
- Occasional lifting, carrying, pushing, and pulling up to 10lbs.
Work Environment:
- Office environment with low noise levels.
Nearest Major Market: Springfield MA