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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
Perform visual, functional, and dimensional inspection on incoming materials, in-process assemblies and finished products
Disposition accepted or rejected parts, or final products, to the appropriate locations
Perform the various standard operating procedures (SOPs), quality work instructions (QWIs) and inspection processes (RIIs) needed to ensure quality products are made at the Medina site
Accurately record all data and observations
Identify non-conforming material and issue nonconformance reports as necessary
Perform quality data entry and reporting as required
Perform other duties as assigned
Requirements:
High School diploma or GED required
Strong math and reading skills
1-2 years experience working in a quality controlled environment. Preferred within regulated industry with cGMP principles (i.e. medical devices)
Experience measuring and inspecting parts, or related experience preferred
Strong verbal and written communication skills
Work an eight (8-10) hour shift and able to work overtime when required to meet deadlines
Knowledge and working application of measurement equipment, i.e., Micrometers, Calipers, Height Gage, Drop Gage, Pin Gages, Microscope
Strong attention to detail with proactive approach to identifying issues
Ability to read and understand engineering drawings used to inspect parts
Knowledge and working application of Zero Acceptance Number Sampling Plans
Knowledge and working application of standard operating procedures
Certification, knowledge and working application of IPC-A-610 Acceptability of Electronic Assemblies
Knowledge and working application of FDA cGMP a plus
Knowledge and working application of ANSI/ISO/Health Canada Requirements a plus
Knowledge and working application of data entry and spreadsheet applications (Microsoft Office)
Working knowledge of medical device regulations, a plus
Must be able to sit, stand, bend, stretch and walk throughout the workday
Must be able to lift and carry at least 20 pounds
Must be able to perform repetitive motion tasks
Work well under tight deadlines
Dynamic Lifting capability: Must have the ability to lift and carry 15 pounds from floor to shoulder and lift 2 pounds from shoulder to overhead
Must also have the capability to push and pull a maximum force of 6 pounds
Nice to have:
Knowledge and working application of FDA cGMP a plus
Knowledge and working application of ANSI/ISO/Health Canada Requirements a plus
Working knowledge of medical device regulations, a plus
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability
business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
educational assistance programs
time-off benefits such as paid holidays
paid time off ranging from 20 to 35 days based on length of service