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Quality/Compliance Manager - Immediate Hire

Instrumedical Technologies, Inc. is a privately held company specializing in the manufacture of high quality, close tolerance, instrumentation and implants for the medical industry.

 

• Driving the development, execution, and completion of the manufacturing quality plan.
• Review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerance, proper use of engineering, process and material specifications.
• Participate in new product development projects
• Work closely with suppliers on interpretation of quality requirements
• Recommend and implement measures to improve production methods, equipment performance, production floor layout, yields, and quality of product.
• Respond to and participate in corrective action implementation to observations identified in internal and external audits.
• Monitor systems and procedures for meeting FDA, QSR, and ISO requirements.
• Maintain ISO compliance with company policies, operating procedures, safety standards, and good housekeeping practices.
• Supervision of Quality Control personnel, inspection/validation techniques, calibration and control all gages and measuring equipment.
• Ensure high level of customer service through investigating and correcting customer issues and complaints relating to quality.
• Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished product. 
• Run quality control training programs
• Work closely with ISO Outsourcing Management, Engineering, and Quality Departments.  Compiles required changes to documents.  Posts changes to computerized control records, release documents, and notify affected departments.

• Bachelor's degree in related discipline. 
• 5 plus years in related work or relevant quality system. 
• Experience in the medical device industry preferred as well as domestic and international regulations for quality certifications. 
• Must have working knowledge of manufacturing, QA procedures and regulatory requirements.
• Knowledge of measurement tools including micrometers, calipers, and digital readouts.
• Familiarity with drafting standards and geometric dimensioning and tolerance.
• Working knowledge of blueprint reading
• Ability to handle project assignments of medium scope and complexity and able to prioritize and complete work in a timely manner.
• Strong understanding of materials concept
• Ability to effectively work in a team to expedite completion of critical tasks.
• Must be knowledgeable in Microsoft Office and be able to learn specialty programs.  Knowledge of Vantage system a plus.
• Excellent people skills and ability to work will all levels of personnel.
• Proactive approach and "sense of urgency" attitude - good planning and organizational skills.