Tigon Medical
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    • Achilles
    • Brostrom
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    • Portfolio
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  • Treatments
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Operations/Quality Engineer

Position Description

This position is responsible for the day to day operations and/or the management of the quality system. 


COMPETENCIES & RESPONSIBILITIES (included but not limited to):  

  • Inventory management (quantities, trending, ordering, etc.)
  • Organize and maintain Design History Records (DHR)
  • Coordinate with sales team to manage and maintain relationship with territories and clients
  • Manage accounts
  • Organize marketing opportunities
  • Responsible for monthly, quarterly, and yearly objectives 
  • Develop, maintain, and implement a quality policy that maintains compliance with applicable Quality System Regulations.
  • Complete Document Change Orders (DCO) document and control processes and procedures. 
  • Actively lead or assist activities in the following areas: Incoming Inspection, Non-Conforming material, CAPA (Corrective and Preventive Actions), Production support, Document Control, Quality Management Reviews, Quality Audits, DHRs, Product Complaints and other associated tasks.. 
  • Work with suppliers, and Production Support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality is monitored and maintained
  • Stay informed on updates to standards and regulations
  • Schedule and perform vendor qualifications and equipment calibrations
  • Assist in the resolution, documentation, customer responses of product complaints. 
  • Participate in conducting internal/vendor audits. 


QUALIFICATIONS:  

  • 4yr degree in applicable field of study, preferably science or engineering
  • 2+ years experience in medical device industry 
  • Quality orientation and high attention to detail
  • Ability to thrive in start-up environment
  • Understanding of quality and regulatory requirements for Class 1 and Class 2 devices
  • Excellent written and verbal communication skills 
  • Project management, self-starter and self-organizer
  • Problem analysis and problem resolution skills
  • Ability and eagerness to learn

Apply

Tigon Medical

303 Najoles Rd. Suite 104, Millersville, Maryland 21108. United States of America

(410) 544-2833

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