NextPhase Medical Devices LLC is a fast-growing, engineering design and contract manufacturer of single-use and electromechanical medical devices, with facilities in Rochester, NH, Mansfield, MA, and Tijuana, Mexico.
Based in our Mansfield, MA facility, the Quality Control Inspector will work with other NextPhase personnel to provide various inspection services within the bounds of our quality management system, following defined AQL inspection sampling plans. The Inspector will follow work instructions and quality inspection plans and inspect components to specific requirements utilizing various tools, including but not limited to visual inspection, digital height gauges, calipers, optical comparators, vision systems, durometers, and more. The Inspector is required to follow Good Documentation Practices and work in compliance with our quality management system which is based on ISO 13485 and 21 CFR 820. The Inspector may also provide in-process inspection services for assemblies and finished medical devices. The Inspector is expected to always be an advocate for our Quality Policy and Core Values.
Other Responsibilities Include:
- Performs incoming material inspection following work instructions and component quality inspection plans.
- Follows specific AQLs where identified.
- Performs first article inspections.
- Properly dispositions and labels inspected materials.
- Performs in-process inspection on subassemblies and finished devices as required.
- Utilizes a variety of inspection tools including but not limited to visual inspection, digital height gauges, calipers, optical comparators, vision systems, durometers, and more.
- Works with operators and supervisors on quality policies and procedures; assists in training of employees on new policies and procedures.
- Determines acceptability of rework by conducting inspections and physical tests of reworked product.
- Documents finished product status by recording and summarizing raw materials, in process, and finished product inspection and physical test data: updating quality assurance databases as required.
Required Skills, Knowledge, and Experience:
- 4+ years in medical device quality assurance or related field.
- A working understanding of ISO 13485 and FDA Quality System regulations.
- Understanding of inspection practices and AQL sampling.
- ERP experience is beneficial.
- Use of inspection tools required.
- Ability to regularly lift/push/carry on average 30 pounds and at times up to 45 pounds
- Ability to see up close and from a distance for visual inspection and evaluation