Quality Assurance Technician
This position ensures that all goods received into Aziyo Biologics, manufactured by Aziyo Biologics or subcontractors, are handled in accordance with internal procedures and inspected in accordance with product specifications to ensure that the products meet visual, physical, dimensional and functional requirements as stated in product/component specifications.
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 Aziyo Biologics 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).
- Following Component Specification/Inspection Requirements appropriately determine sample size via statistical sampling plan (ASQ Z1.4 or C=0 plans); properly samples product in accordance with procedures/ specifications.
- Properly identifies and segregates product as to its inspection status (Pending, Reject, Accept etc.).
- Promote, adhere to, and ensure compliance to FDA Good Manufacturing Practices (cGMP)
Associates degree or higher preferred. High school diploma with relevant work experience required.
Experience and Skills
Work Experience Required:
- 3 – 5 years’ experience in medical device manufacturing QA/QC: inspection and/or verification of incoming materials, production samples, packaging samples, and/or labeling samples.
Specialized Skills, Knowledge:
- 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.
- Good 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. Must be detail oriented.
- Ability to perform detail-oriented work with a very high degree of accuracy.
- None Required
Quality Management System (QMS) Responsibilities
Identification and Traceability, Inspection, Measurement and Test Equipment, Acceptance activities, Nonconforming product, Labeling and Packaging Control, Process Validation and Statistical Techniques.
QMS Process Ownership Responsibilities: 1) Monitor QMS subsystem(s) to ensure compliance to SOP requirements. 2) Participate in QMS activities associated with the subsystem(s) (meetings, activities, etc.). Act as auditee for internal audits associated with the QMS subsystem(s). 3) Review the performance and health of the QMS subsystem(s) with Quality Management and/or Management Representative prior to management review meetings. 4)If identified, inform the Management Representative of any issues or potential deficiencies associated with the subsystem(s).