ob Title: Quality Control Inspector II Department: Quality Reports to: Quality Control Inspector Supervisor FLSA Status: Non-Exempt
Job Summary and Objectives:
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 that 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.
Essential Duties and 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 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. · Maintains quality assurance operations by following quality assurance policies and procedures, reporting needed changes. · May participate in audits. · Perform packing line and manufacturing inspection 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 NextPhase Medical Devices LLC may from time-to-time assign to the employee.
Supervisory Responsibilities:
· Does not regularly supervise employees.
Required Qualifications and Work Experience:
· Minimum Education and Experience:
· 2-5 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. · Use of inspection tools required.
· Skills/Abilities:
· Proficient use of optical comparators, vision systems, height gauges, durometers, and other metrology equipment. · Working knowledge of ISO 13485 and FDA QMSR · Understanding of statistical sampling and AQL methodologies. · Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) in English. · Ability to work with minimal supervision autonomously and in a team environment. · Take responsibility for task and time management. · Attention to detail to understand and meet the requirements. · Ability to work with others collaboratively.
Preferred Qualifications and Work Experience:
- Education and Experience:
- ERP experience is required
- Additional Eligibility Qualifications:
- ASQ Certification is beneficial.
Physical Demands:
- Full range of motion for wrist, hand, and finger dexterity.
- Ability to frequently sit, stand, walk, stoop, kneel, and crouch.
- 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 assembly and evaluation.
Work Environment:
- Physical Setting: Busy, professional office and manufacturing environment.
- Culture: A diverse and inclusive culture that respects and values individual contributions.
- Dress Code: Business casual attire to promote a professional yet comfortable workplace.
- Core Business Hours: 8:00am to 5:00pm.
Additional Information:
- This position requires 100% on-site attendance.
- Verifies work affecting quality independently and has the authority to perform these tasks as stated in the Essential Duties and Responsibilities section.
Job Description is a Guideline Only:
· This job description is a summary of the main functions and responsibilities of this position as it currently exists. It is not intended to be a complete and exhaustive list or description and may evolve and change over time in accordance with business and market demands. · This job description is also not a contract, and NextPhase Medical Devices LLC may from time-to-time in its discretion revise, amend, and update this job description to better reflect the actual functions and responsibilities the employee performs. · Duties, responsibilities, and activities may change at any time with or without notice.
Equal Employment Opportunity Statement:
· NextPhase Medical Devices LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, c