- We are seeking a meticulous QA Inspector III to join our team in Medina. In this critical role, you will be responsible for the final quality assurance and release of medical infusion pumps and wireless battery modules. You will ensure that every device meets rigorous safety and performance specifications before it reaches the healthcare field.
- Shift: Monday - Friday, 5:30 AM - 4:30 PM (OT as needed)
location: Medina, New York
job type: Contract
salary: $23.00 - 26.75 per hour
work hours: 7 to 3
education: High School
responsibilities:
- Documentation Review: Audit Device History Records (DHR) using paper and electronic Manufacturing Execution Systems (Camstar) to ensure all test procedures are complete and compliant.
- Visual Inspection: Conduct final visual assessments of pumps and battery modules, ensuring all labeling and physical attributes meet FDA release specifications.
- Systems Management: Approve product releases within JDE (B4ONE/GME) ERP systems and manage nonconformance tracking.
- Compliance & Disposition: Accurately record failing observations, disposition rework activities, and ensure the closure of nonconformances in the approved electronic system.
- Process Control: Monitor maintenance procedures and recognize out-of-tolerance situations, taking immediate corrective action to maintain quality standards.
qualifications:
- Education: High School Diploma or GED required.
- Experience: Previous experience in a pharmaceutical, biotech, or medical device environment is highly preferred.
- Technical Skills: Proficiency in cGMP and FDA documentation standards, ESD (Electrostatic Discharge) requirements, and basic spreadsheet/data entry applications.
- Physical Requirements: Ability to sit or stand for long periods, perform repetitive hand/finger motions, and lift up to 25 lbs. Excellent color vision and hand-eye coordination are required to identify foreign matter or defects.
skills: Good Manufacturing Practices (GMP), Quality Assurance (QA), Food and Drug Administration (FDA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
