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.
- 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.
- 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