Quality Assurance Specialist

Job Summary

This position is responsible for a combination of functions within Quality including device history record review and release, inspection/testing (equipment management, inspection/testing, quarantine control and documentation.

Job Details/Responsibilities

1.    Documentation: Prepare documentation in accordance with Quality Management System requirements.  This includes but is not limited to ECOs, lab notebooks, testing results, etc.  Maintain all Incoming Quality Assurance (IQA) records, Quality Assurance (QA) release logs, Equipment files, and databases e.g. Inspection records NCMR, etc.  

2.    Device History Records (DHR) / Product Release:   Review and release DHRs and Product Release documentation to ensure compliance with Quality System requirements and within electronic database software (e.g. SAP).  Notify management regarding discrepancies or irregularities.  Maintain hard copy files.  Monitor and report trending data monthly quality reports

3.    Receiving and Inspection: Act as the secondary agent for receiving activities regarding materials with Purchase Orders per released procedures, ensuring correct items, quantity, and documents are provided by suppliers.  This may include stock components, non-stock materials, or service contracts.  Ensure all receiving activities are current and correctly entered into electronic database software (e.g. SAP). Coordinate with purchasing and engineering to ensure correct non-stock or service Purchase Orders are completed correctly. 
 
4.    Quarantine Control:  Maintain quarantine locations for incoming materials, NCMR materials, non-sterile outgoing product, and sterile product prior to release.  Other quarantine requirements may be created as needed. 
 
5.    Inventory:  Provide operations with support regarding current inventory, cycle counts, and database accuracy.  Act as a backup for Operations Specialist for inventory control / reorder status. 
 
6.    Inspection/Testing:  Perform inspection/testing activities pertaining to manufacturing in process, Incoming (IQA), First Article Inspections (FAI), final packaging, and final lot release testing (QI). Generate detailed and accurate inspection and testing reports in accordance with Current Good Documentation Practices (cGDP) and company Quality Management System requirements. Train and oversee new inspectors to ensure consistent work and compliance with established processes. 

Job Responsibilities (continued)

7.    Document Control:  Act as backup for Document Control Specialist. Process engineering change orders.
 
8.    Equipment Management:  Act as backup for Equipment Coordinator for the Equipment Management program. Responsible for monitoring, maintaining and optimizing performance of the equipment management SOP and related documents, including maintaining records ensuring documentation follows SOP and quality requirements. Complete documentation and forms for equipment evaluation and implementation.  Review and approve equipment documentation in accordance with Quality system requirements. Work with Engineering staff to ensure equipment qualification requirements are completed in accordance with released procedures.  

9.    Sterile Load:  Prepare finished goods for Sterilization by outside facilities.  Coordinate and track product status, schedule, and location. Perform required receiving inspections and processes per released documentation.  Prepare release sterile product for shipment to distribution warehouse May be required to prepare test requests and manage sterilization documentation in accordance with Quality System and company requirements.  
 
10.    NCMR and CAPA:  As needed, generate and assist in the investigation of NCMR’s and 
CAPA’s.  Work with Engineering staff to resolve issues in a timely and effective manner.  
 
11.    SAP:  Function as a user on SAP Quality-related modules.  
 
12.    Returned Goods:  Process any return goods product as required.  
 
13.    Responsibilities to the Quality System:  Support the Quality System and Quality Policy.  Be aware of Quality System procedures and requirements, including regulatory requirements, training requirements for position activities. Assist in performing internal audits, if necessary. Inform responsible personnel of concerns involving product quality. 
 
14.    Safety:  Performs job functions in a safe and effective manner.  Adhere to the safety procedures of the company. 
 
15.    Other Duties:  As assigned. 
 

Knowledge, Skills and Abilities (KSA)

• • Must be able to clearly document activities.
  • Ability to use testing equipment such as but not limited to Microscope, Instron, video inspection systems, etc.
  • Able to interpret and read technical specifications and mechanical drawings. 
  • Strong working knowledge of QSR, MDD and ISO 13485. 
  • Ability to use Excel in recording testing statistics.
  • Ability to research and identify products and vendors as needed through different channels, including internet.
  • Some exposure to CAD software such as Auto cad, Solid works, Pro E.
  • Excellent communications skills (both written and verbal).
  • Ability to work independently and in team setting.

Qualifications/ Background Experiences

• • Associate degree required or equivalent combination of education, training and experience in technical discipline.
  • Minimum of 5 years in medical device or similar product design and/or manufacturing required.
  • Minimum of 3 years performing QA inspections/testing activities pertaining to IQA, in process, lot release and Verification and Validation (V&V) required.