QA Technician - Incoming

Benefits:

• Medical-Dental-Vision
• Generous PTO Schedule
• Corporate Gym Discount
• 401(k)
• Well-Being Programs / LifeBalance Discount Program
• Life & AD&D Life Insurance
• Long-Term & Short-Term Disability
• Tax Savings, plus more...

Responsibilities of the QA Technician - Incoming:

• Perform inspections of incoming and returned-from-field products using numerous types of inspection equipment (Smartscope, comparator, calipers, micrometers, etc.). 
• Conduct incoming receiving inspection; finished product/certificates of conformance/material certification; document reviews for accuracy and adherenceto specifications. 
• Create nonconformance reports for customer complaints and supplier nonconformances. 
• Perform first article inspections and communicate results to Supplier Quality. 
• Participate in part and process testing as part of validations. 
• May assist in the development and maintenance of Document Control and Record Control systems that meet FDA, AATB, and ISO standards and regulations. 
• Assist in the completion and retention of documentation pertaining to SOPs. Understand the importance of completing and maintaining documents and records without any errors. 
• Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required.
• Write and revise a variety of technical documents including SOPs (Standard Operating Procedures), quality standards and specifications, training documents, and inspection and testing protocols as needed and assigned. 
• Participate in the completion of Device History Records (DHR). 
• Respond to and prioritize requests for Document Numbers, Part Numbers, etc. and maintain adequate records and updating, In-Use Logs as necessary. 

Requirements for the QA Technician - Incoming:

• Minimum high school diploma or equivalent. 
• Three (3) years’ medical device industry experience in quality control is preferred. 
• ASQ Certified Quality Technician; Vocational Training; AA Degree is preferred. 
• Knowledge of FDA, ISO, and AATB quality system requirements as applicable. 
• Must have strong knowledge of Metrology and GD&T principals. 
• Must have knowledge of basic statistical tools (mean, attribute sampling plans, AQL). 
• Must have experience with typical inspection tools (caliper, micrometer, height gauge, optical comparator). 
• Experience with automated inspection methods (CMM, Vision Systems) is preferred. 
• Must have knowledge of calibration principals. 
• Ability to write, review, and edit technical reports and SOPs. 
• Proficient computer skills required such as basic knowledge of MS Word, Excel, Power Point, Outlook, and other software as necessary. 

Working Conditions 

• ·Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments. Work may require occasional weekend/evening work and 4+ hours of standing. 
• Duties may include contact with human tissue, blood, bone, and fluids. 

Health and Safety 

• Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products. 
• This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves. 
• Will require experience or training in the routine handling of chemicals and biohazards. 
• May require OSHA (bloodborne pathogen) training, MSDS/SDS, and other safety training as applicable. 
• Must be able to lift 60 lbs. 

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