Job #10245: Quality Assurance Manager
Title: Quality Assurance Manager
Date Posted: 04/30/2018
Job Location: MA
Quality Assurance Manager
Manufacturer of medical devices and industrial tooling is looking for a full-time HandsOn Quality Assurance Manager responsible for the shipping, inventory and quality departments. In this position you will create, document and implement inspection criteria and procedures operating under an ISO 13485 certified Quality Management System. Responsible for identifying, analyzing and developing continuous improvements in productivity, quality, client relationships, and customer service. A thorough understanding of mechanical measurements to specifications and GD&T requirements in a CMM machining environment desired.
· Management Representative.
· Manage and maintain the ISO business system for Medical Devices and Industrial
· Document and maintain quality control standards
· Assist with receiving, first piece, in process, and final inspections for new products as required.
· Create and direct environment test functions and applications.
· Participates in corrective action including investigation, root cause analysis, corrective action, and preventive actions.
· Ensure activities assigned are performed in accordance with Quality Management System. Provides technical assistance and training to production and manufacturing engineering personnel.
· Coordinate internal audits process. Oversee all quality and safety audits, maintain records and coordinate response/closure to findings.
· Coordinate the Management Review process Qualifications:
· Broad knowledge of FDA Quality System Regulations and ISO 13485 Standard.
· Proficient with CMM shop math, and mechanical inspection instruments, and blue prints.
· Strong analytical skills and the ability to express technical concepts effectively, both written and verbal.
· Proficient at data collection, analysis, and presentation.
· Strong communication skills and ability to work closely with external and internal customers
· Supervisory Management Experience Education and/or Experience
· Bachelor Degree; or 10 years related experience and/or training; or equivalent combination of education and experience