JOB TITLE: Quality Technician – Inspection and DHR
JOB PROFILE: QUALITY TECHNICIAN II (Site Quality Family)
Level S05 (IL)
- Assist with the establishment and implementation of standard processes and improvements that ensure quality targets are achieved or exceeded.
- Provide day to day operational support to supervisor for Inspection and DHR areas
POSITION DUTIES & RESPONSIBILITIES:
- Provide day to day support by managing resources, business priorities, and quality non-conformances
- Assist in collecting and providing performance metrics and analysis for the department
- Serves as backup inspector: Inspects incoming, in process and finished products and material for visual, mechanical, and dimensional characteristics, using inspection sheets and applicable sampling plans
- Serves as backup DHR reviewer: Performs DHR review and “Release to Branch Plant” function including document verification and recording incoming inspection inventory
- Lead training and certification process for new employees and existing employees on new pieces of equipment
- Manage “Roving auditor” program involving inspection of product in manufacturing cells
- Manage DHR certification process and interacts with JJMD to maintain this process
- Performs filing and manages the imaging and verification processes for Device History Records
- Assess business performance, analyze business processes, evaluate gaps, identify process improvements, and recommend business solutions
- Assist in executing projects that increase process efficiencies, reduce cycle time, cost, and improve overall quality of execution
- Design, organize and implement continuous improvement projects pertaining to inspection, final release and product flow
- Ability to handle multiple priorities in a consistent and effective manner in fast-paced environment.
- Ability to navigate “gray areas” and make informed quality decisions
- Cooperative attitude and team building skills
- Desire to work with multifunctional teams (production, quality engineering) to ensure successful operational outcomes
EDUCATION AND EXPERIENCE REQUIREMENTS:
- High school diploma or equivalent.
- ASQ (American Society for Quality) courses desirable.
- Minimum of five years of experience utilizing inspection techniques in Medical device or Pharmaceutical Industry.
- Experience with MRP/ERP systems, preferred.
- Strong GMP background and knowledge of appropriate FDA regulations desirable, with medical device experience preferred.
- Strong verbal and written communication skills required.
- Microsoft Office (Word, Excel, etc.) skills required.
- Vision in both eyes must be at least 20/30 or correctable to 20/30 and capable of color verification.
- Ability to read and interpret measuring instruments, including but not limited to: calipers, micrometers, dial indicators, optical comparators, plug gauges, hardness testers, etc.
- Lifting weight up to 20 pounds on regular basis and up to 50 pounds on occasional basis.
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