Quality Technician

Position Summary

The Quality Technician is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Technician supports production and quality operations by assisting in performing and documenting problem solving investigations, conducting pre-reviews of Customer product and run set-up and final acceptance/run release through review of run records/device history records. 

Quality Technicians assist in identifying, documenting and investigating non-conformances, Customer complaints, CAPAs and internal/external audit findings.  They work with operations and quality team members to perform and document problem-solving investigations and continuous improvement initiatives.  In addition, to performing run releases, Quality Technicians may execute review of calibration and operating logs.

Duties

1. Conducts pre-review on incoming product to confirm compliance to the Customer’s processing specifications, verifies calculations, correct dose range, approved product codes, dosimeter placements and special instructions. 
2. In Lab facilities, review and release laboratory reports, ensuring tests comply with requirements and Customer requests. 
3. Assists in Quality investigations, associated problem-solving activities and continuous improvement initiatives. 
4. Identifies, documents and investigates non-conformances to establish sustainable corrective actions.  Supports investigations into Customer complaints and internal/external audit observations. 

Duties - cont'd

1. Assist in the development (and revisions to) quality system policies and procedures.
2. Executes review of operating logs (i.e. spectrophotometer, pre-conditioning, aeration), preventive maintenance schedules, maintenance work orders, and site calibration activities to ensure timely and accurate recordkeeping.  Responsible to escalate matters of non-compliance to site Quality Lead/Manager.   
3. Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations. 
4. Complete other duties as assigned.

Education Degree

Required Experience

1. Ability to work in a fast-paced, regulated environment with strict deadlines
2. Mathematical skills including ratios, proportions, basic algebra
3. Ability to generate detailed, high quality documentation. 
4. Ability to work with others in analyzing and solving technical problems.
5. Teamwork: Collaborates with others. Works in a professional manner to support team actions. 
6. Effectively manages work tasks.  Is detail oriented and strives for continuous improvement.
7. Above average organizational skills
8. PC experience and working familiarity of common desktop applications including Excel and Word.