Job Description

    JOB DESCRIPTION: The QA
 Analyst/Inspector is responsible for conducting inspections of materials,
 subassemblies and finished product, as well as, evaluating quality data
 collected throughout the manufacturing process and the field to determine root
 cause, trends, failure rate, etc. 

Conducting incoming, in-process and final QA inspections to
 verify product meets specifications.  

Evaluations include visual and physical examination,
 functional testing, data analysis and dimensional analysis using a variety of
 equipment, software and gauges.  Reports to Quality Manager.     

Primary Responsibilities 

· Analyze
manufacturing and field data to determine trends, product conformance, costs
of nonconformance, failure rate and on-time delivery. 

· Drive
corrective & preventive actions to resolution. 

· Work
as team member to continually improve quality management system. 

· Must
be able to accurately read/interpret engineering drawings and other similar
specifications. 

· Identify
procedural deficiencies & Update quality system procedures as needed. 

· Conduct
and document process & material inspections in accordance with
specifications. 

· Samples
product and labels according to established sampling plans and documented
instructions. 

· Identifies
and segregates nonconforming materials in accordance with documented
instructions.  

· Accurate
and timely completion of inspection reports, NC reports, logs and other
records is required. 

· Works
in an organized manner at all times, to ensure lot traceability and to prevent
mix-ups. 

· Adheres
to all regulations, safety rules/practices and organizational policies and
procedures. 

· Project
and/or responsibility tasks oriented to assist engineering with continuous improvement
activities. 

Secondary Responsibilities 

· Project
responsibilities, to be defined by management, to meet business needs; tasks
to assist manufacturing, engineering and other personnel with D&D
projects, validation, verification, etc. 

Qualifications and Education Requirements 

· Associates
degree or technical certification desired. 

· A
minimum of 3 years’ experience working in a manufacturing or similar is
required.  

· Must have computer
skills, including MS Word, MS Outlook, Excel, and PowerPoint. Access skills desired. Excel skills
required include formula creation/modification, filters, sorting, data
validation and conditional formatting.  

· Medical
device/pharma/ISO experience highly desired. 

· Good oral and
writing skills required. Must be able
to speak, read and write the English language and perform basic mathematical calculations
   

· Competent
with inspection techniques and common inspection equipment and gauges,
including calipers, micrometers, scales, multi-meters, and pressure gauges,
is required. Precision/Vision measurement system experience desired. 

Physical Requirements 

Must
be able to lift up to 50 lbs. 

Must
be able to stand or sit for an extended period of time. 

Must
be able to push/pull carts loaded with boxes/products for evaluation/inspection. 

Vision:
Must be able to distinguish colors and have close visual acuity to perform
activities such as: preparing and analyzing data and figures; transcribing;
viewing a computer terminal; extensive reading; visual inspection involving
small defects, small parts, and/or operation of machines (including
inspection); using measurement devices; and/or assembly or fabrication parts
at distances close to the eyes. 

work environment 

Office, lab, production and warehouse setting.