Quality Manager – Florida
Type: Quality Control / Quality Assurance
INDUSTRY: Orthopedic Implants, Trauma Hardware, Surgical Instruments
LOCATION: Naples, Florida
INCOME: up to $120K year
There is a relocation assistance package offered to help new employees transition to Florida.
WHY THIS COMPANY:
· Consistent growth between 10% - 15% for last 10 years.
· Culture committed to quality and team work.
· 100% company paid health, dental, vision, life and disability insurance for their valued employees.
· 401K with company match and profit sharing.
· Longevity of employees.
Performs management level quality control tasks in a medical device / FDA certified manufacturing environment. This position manages all aspects of quality including maintaining certifications, managing customer complaints, conducting continuous improvements and developing quality plans for continued success. Lead, manage, develop and motivate a world class team of quality professionals.
A division of a world class corporation continues to consistently grow by double digits. The growth is a result of their commitment to quality and team of valued employees. The division has been investing in new equipment, technology and software. Many of their employees enjoy longevity and career advancement.
Keywords related to job opening: QC manager, quality control manager, quality assurance manager, medical device, orthopedic, orthopedic implants, ISO-13485, ISO13495, fda, fda 21CFR820, medical
· Manages, schedules and priorities work load inspection, first articles inspections, CMM programming and quality inspection activities.
· Manages documents, tracks and trends, customer complaints, non-conformance, corrective and preventative actions.
· Manages process validations, special requirements, capability studies, gage R&R, and statistical analysis.
· Manages quality system procedures, forms and work instructions.
· Maintains and improves the ISO-13485 quality management systems.
· Manages calibration systems for gages and lab equipment.
· Manages engineering change orders (ECO) device revision changes, disposition of materials and containment.
· Authorizes the material review board (MRB) to rework devices or dispose of material.
· Coordinates or performs the inspection or sorting of devices.
· Coordinate internal and external audits.
· Serves as the company’s quality management representative responding to customer needs and requirements.
· Leads, guides, directs, coaches, develops and mentors quality engineers, technicians, and programmers, inspectors and quality controls professionals.
· Plans and coordinates work, assigns projects, sets goals and objective.
· A Bachelors or Associates degree and/or related experience supplemented by a minimum of 8 years of experience in quality control, 3 years of supervision and equivalent combination of education, certifications and training.
· Lean/Six sigma training certifications is preferred.
· Strong Gd&T, metrology skills and the ability to measure close tolerance machined components.