Quality Specialist

Description

Position Summary:

The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC.

This is an entry-level position. Depending on the sub-unit, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventive maintenance on tools and equipment, and/or maintain Quality system documents. Timely and accurate work is expected. This position regularly interacts and collaborates with other departments within the company.

Primary Duties

• Perform all work in compliance with company policy and within the guidelines of its Quality System.
• Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
• May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
• Perform inspection of incoming materials using basic and advanced measurement tools
• Perform quarantine activities including physical and electronic segregation, labeling, physical and electronic release
• Perform second person verifications
• Initiate NCRs with a thorough description of the nonconformance including target as well as discrepancy, quantity and standard used for rejection
• Perform rework activities to completion
• Identify need for WID updates
• Support validation testing, e.g. GR&R and program validations
• Comparison of defined aspects of physical materials to written specifications to determine compliance.
• Determine suitability of manufactured materials for release to manufacturing.
• Determine compliance of equipment with calibration requirements.
  
  

Supplemental Data

Minimal domestic travel may be required for training purposes

Training, Education And Experience

• High school diploma or equivalent is required.
• Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.
• Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
• Minimum 1-year previous on-the-job experience in a Quality Inspection position using simple and advanced metrology tools.
• Experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.
  
  

Knowledge, Skills And Abilities

• Effective written and verbal communication skills.
• Proficiency in MS Office tools, including Outlook, Word, and Excel.
• General computer operation.
• Attention to detail is fundamental to this position.
• Ability to accurately follow written and verbal instructions.
• Organization skills as needed to maintain paperwork and task schedule.
• Proficiency in internet navigation.
• Basic math proficiency.
  
  

Physical Requirements

• Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
• Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation. Must be able to travel (if necessary).
• Must be able to wear PPE correctly for most of the day.
• Must be able to distinguish colors.