Quality Control Inspector

The Quality Control Inspector will be engaged in a variety of mission-critical activities supporting the manufacturing and sale of a medical device. Responsibilities will include:  incoming inspection, in process and final inspection, materials and inventory management, NCR generation, control of nonconforming materials, calibration maintenance, environmental monitoring, DHR reviews, and other assigned duties as necessary.

RESPONSIBILITIES

• Performs physical inspection and testing on components and sub-assemblies intended to be used in the manufacturing of a medical device
• Performs physical inspection of in-process assemblies and related documents during manufacturing in a controlled environment
• Processes inbound & outbound shipments
• Performs environmental monitoring activities in support of a Class 8 Controlled Environment
• Manages and maintains calibration schedules
• Maintains inventory integrity for all materials
• Reviews and approves Device History Records to support product release
• Initiates Nonconforming Material Reports and manages affected materials
• Develops and archives quality records
• Proposes improvements to enhance efficiency
• Implements modifies to Standard Operating Procedures (SOP’s).
• Maintains databases related to the above functions.

Qualifications

• High School diploma or equivalent certification; Bachelor’s degree preferred
• Ability to read mechanical drawings
• Experience with various mechanical inspection and testing techniques such as vision systems, surface plate set-up, hand tools, tensile testers, leak testers, etc.
• Rigorous attention to detail with strong organizational and interpersonal skills
• Strong verbal and written communication skills with the ability to work both independently and within a team environment
• Can-do attitude with a willingness to take initiative and solve problems creatively, independently and efficiently
• Ability to handle multiple assignments in a fast-paced environment
• Ability to uphold a high standard for professionalism
• Confidence with Microsoft Office applications; Minitab experience is a plus
• Confidence with basic mathematics
• Experience in the medical device field mandatory