Quality Inspector

NextPhase Medical Devices; Mansfield (OH); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in the medical device field is seeking a Quality Control Inspector to ensure product quality and compliance with standards. The role involves conducting inspections, documenting quality data, and collaborating with production staff. The ideal candidate will have extensive experience in quality assurance within the medical device industry and a solid understanding of FDA regulations.

Qualifications

• 4+ years in medical device quality assurance or related field.
• Understanding of FDA Quality System regulations.

Responsibilities

• Conducts inspections and verifies specifications with engineering staff.
• Documents finished product status and maintains quality documentation.
• Performs packing line and manufacturing inspections.

Skills

Communication

Teamwork

Attention to Detail

Task Management

Education

4+ years in medical device quality assurance

Understanding of FDA Quality System regulations

Job description

Position Title: Quality Control Inspector

Reports to: Quality Control Inspector Supervisor

Direct Reports (Yes/No): No

Job Summary

The Quality Control Inspector will work with other NextPhase personnel to maintain a corporate quality system. NextPhase is a contract Research and Development & OEM company in the medical device field, working on several new technologies. NextPhase Medical Devices specializes in the design, development, validation, and manufacturing of Class II and Class Ill therapeutic and diagnostic devices.

Duties/Responsibilities

• Determines quality and reliability standards by studying drawings and formulas, verifying specifications with the engineering staff.
• Identifies process product condition by collecting samples during the production process, conducting in-process inspections, and first article approvals.
• Works with operators and supervisors on quality policies and procedures; assists in training of employees on new policies and procedures.
• Determines the acceptability of rework by conducting inspections and physical tests of the 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 database.
• Maintains product quality documentation system by writing or rewriting quality assurance procedures.
• Maintains quality assurance operations by following quality assurance policies and procedures, reporting needed changes.
• Assist production manager with setting up jobs for production, including gathering all documentation and tooling as required.
• Responsible for product inspection and/or audits of quality control programs.
• Perform packing line and manufacturing inspection.
• 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.
  
  

Other Duties

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Required Skills/Abilities

• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
• Ability to work with minimal supervision in a team environment.
• Take responsibility for task and time management.
• Ability to learn new tasks quickly.
• Attention to detail to understand and meet the requirements.
• Ability to access, open, and save files to a computer.
• Ability to work with others collaboratively.
  
  

Education And Experience

• 4+ years in medical device quality assurance or related field.
• A working understanding of FDA Quality System regulations.
  
  

Physical Requirements

• Full range of motion for wrist, hand, and finger dexterity.
• Sitting, working at a computer for long periods of time.
  
  

On-Site/Remote Attendance

This position requires 100% on-site attendance.

3:00PM - 11:30PM