Medical Device Quality Inspector – 2nd Shift

Arterex Medical; Mansfield (MA); On-site; USD 28,000 - 39,000; Full time

Job summary

NextPhaseMedical Devices LLC is seeking a Quality Inspector for the 2nd shift in Mansfield, MA. The role focuses on inspecting components and assemblies in support of our ISO 13485/QSR quality system and includes use of precision tools and vision systems.

The successful candidate will perform incoming and in-process inspections, support root-cause analysis, and ensure documentation accuracy while adhering to quality policies. Experience with AQL sampling and medical device standards is required.

Qualifications

• 4+ years in medical device quality assurance or related field.
• Understanding of ISO 13485 and FDA Quality System regulations.
• Understanding of inspection practices and AQL sampling.
• Use of inspection tools required.

Responsibilities

• 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 visual inspection, digital height gauges, calipers, optical comparators, vision systems, durometers, and more.
• Works with operators and supervisors on quality policies and procedures; assists 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.
• Maintains quality assurance operations by following quality assurance policies and procedures, reporting needed changes.
• May participate in audits.
• Perform packing line and manufacturing inspections as needed.
• Perform sampling and testing of components, materials, and equipment.
• Ensure that raw materials and products meet company standards.
• Determine methods, sequences, and procedures necessary for inspection.
• Interpret manufacturing drawings, diagrams, and specifications to approve or reject units or systems.
• Adapt measuring devices and procedures.
• Apply approval or rejection labels to raw materials once analytical data is evaluated.
• Perform such other functions, responsibilities, tasks and/or projects that are reasonably related to the above essential job functions and responsibilities and/or as NextPhaseMedical Devices LLC may from time-to-time assign to the employee.

Skills

Attention to detail

English communication

Teamwork

Self-motivation

Education

4+ years in medical device QA

Tools

Digital height gauges

Calipers

Optical comparators

Vision systems

Durometers

Job description

NextPhaseMedical Devices LLC is seeking a Quality Inspector for the 2nd shift in Mansfield, MA. The role focuses on inspecting components and assemblies in support of our ISO 13485/QSR quality system and includes use of precision tools and vision systems.

The successful candidate will perform incoming and in-process inspections, support root-cause analysis, and ensure documentation accuracy while adhering to quality policies. Experience with AQL sampling and medical device standards is required.