Spherion Gainesville FL is seeking a Quality Assurance Technician for a prominent and fast paced client to ensure all products meet product specifications prior to final acceptance. This includes review and completion of applicable
documentation. Additionally, these tasks shall be accomplished in compliance with FDA and ISO Standards as delineated by the Quality Management System. This will be a 6 month assignment.
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Responsibilities:
- Perform and document inspection requirements following approved SOPs and WIs for incoming and finished products including implants, instrumentation, raw material, and trays.
- Document and notify QC Supervisor / Manager of non-conformances (NC).
- Create NC record, segregate NC product, and completion of NC system tasks as assigned by QC Supervisor/Manager.
- Assist with Material Review Board process and execute NC dispositions.
- Perform product inspection in accordance to established Sampling Plans.
- Maintain ERP system status and location of product to ensure accurate identification and traceability.
- Perform Stock Audits as assigned by QC Supervisor / Manager.
- As needed - Perform Environmental Monitoring tasks.
- Perform First Article Inspection (FAI) and/or Special Inspections (SI) per established procedures.
- Know and apply the Quality System and any appropriate Federal and International standards.
- Assist and support other employees, teams, and sales personnel as necessary.
Working hours: 7:00 AM - 3:30 PM
Skills:
- Prior work in a Quality department in a regulated industry preferred.
- Experience utilizing Geometric Dimensioning and Tolerancing (GD&T) preferred.
Education:
High School
Experience:
1-4 years
Qualifications:
- Attention to detail, accuracy, and documentation skills.
- Aptitude to learn the use of basic Quality measurement equipment and tools such as profile overlays, calipers, hand gages, etc.
- Basic computer skills
- Familiar with 21 CFR Part 820 and ISO-13485 subclauses on Acceptance Criteria.
- Entry level understanding of GD&T ASME Y14.5.
- Ability to use Micrometers, Calipers, Depth-gauge, Height gauge, Visual Comparator, and Vision-System.
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At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).