Quality Technician

Essential Duties & Responsibilities

• Inspects incoming product (components, subassemblies, labeling, finished goods) in accordance with internal facility standard operating procedures/work instructions or Part/Product Specifications.
• Inspects Elutia’s manufactured, packaged, and labeled product in accordance with internal facility standard operating procedures/work instructions or Product Specifications.
• Follow documented procedures or test procedures to evaluate identified characteristics for conformance to product specifications via visual inspections (aided or unaided eye), functional testing, or physical testing via visual measurement system or Instron tensile equipment.
• Maintains accurate, legible, and organized records of performed inspections in compliance with Good Documentation Practices, and properly prepares / reviews inspection paperwork.
• Prepares nonconformance documentation (where appropriate), and assists with Root Cause Analysis where needed.
• Other duties as required.

Education & Experience: 

• High school diploma with relevant work experience.
• 3+ years’ experience in medical device manufacturing QA/QC: inspection and/or verification of incoming materials, production samples, packaging samples, and/or labeling samples.
• Ability to use common measurement equipment (e.g., pin gauges, calipers, micrometers, visual measurement systems, steel rulers, and Instron tensile testing equipment).
• Ability to read and interpret engineering drawings/specs and capable of distinguishing between colors (component distinction and printed labeling).
• Experience working in both English and Metric systems of units.
• Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals.
• Proficient in the use of MS Office applications and electronic documentation systems.
• Excellent written and verbal communication skills. Self-starter, able to work independently with little direct supervision, is team oriented, and works well within group situations.
• Responsible decision maker: ability to reason and make sound decisions.
• Ability to perform detail-oriented work with a very high degree of accuracy.
• Basic understanding of FDA 21 CRF 820 (cGMP), and ISO 13485 is preferred.

Salary Range: $20-28/hour based on relevant work experience