Specification Analyst

Innovate Medical, LLC   Johnson City, TN   Full-time     Quality Control
Posted on November 4, 2022

Are you looking for a full-time, challenging, and enriching position in a family-like company? Our Specification Analyst position may be exactly what you're looking for!

Hourly Pay: $18-$22/hr (M-F; 8:30-5)

Medical and Dental Insurance available

Vacation and PTO benefits

The Specification Analyst role is to maintain product integrity by ensuring that written product specifications are current and approved and that production and inspection procedures support said specifications.  The Specification Analyst serves a key role in ensuring that product and process changes are implemented in a controlled manner in compliance with the company Engineering Change Control System.  This position is also responsible for scheduling and monitoring the ongoing routine product testing to ensure continued specification compliance.

Education, Training, and Experience

  • Bachelor or Associate degree in science/tech
  • ISO Standard training - preferred
  • Experience in quality, regulatory, or engineering position - preferred
  • Risk analysis, packaging, validation, and sterilization experience– useful but not required

Special Requirements

  • Proficient in Microsoft Excel and Word
  • Good written and oral communication
  • Effective leadership for coordinating changes across multiple departments
  • Project planning
  • Self-monitoring with project “ownership” mentality
  • Graphic design – useful but not required

Essential Duties and Responsibilities

  • Communicate with sales, purchasing, operations, quality, and regulatory management to identify product attributes that should be specified to ensure product acceptance
  • Use product requirements input to develop approved product, packaging, and labeling specifications
  • Compile specification data into written quality system documents
  • Follow company Engineering Change Control system to create or change production and product specification documentation for use by Quality Manager for controlled implementation of changes
  • Serve as product specification representative to coordinate product and process testing for qualification of products against the specification
  • Conduct product specification audits to ensure continued production and inspection compliance
  • Manage product testing and auditing schedule

Physical Demands

  • Excellent hearing, speaking and communication abilities
  • Exposure to moderate noise
  • Frequent walking and standing for extended periods
  • Adequate close, distance, peripheral, and color vision abilities
  • Extended periods of sitting at a desk and working on a computer

Innovate Medical, LLC

2210 Buffalo Rd
Johnson City , TN