Quality Assurance Inspector

Quality Assurance Inspector I

Position Summary: The Quality Assurance Inspector I is responsible for performing incoming, in-process, and finished device inspections to ensure compliance with established specifications. The position supports quality system activities through the use of electronic quality management systems (eQMS), accurate documentation of inspection results, and collection and analysis of quality data.

Essential Duties and Responsibilities:

• Perform incoming inspection of raw materials, components, and supplier-provided products against approved specifications, drawings, inspection plans, and acceptance criteria to determine material acceptance or rejection.
• Document inspection results and quality records in accordance with Good Documentation Practices (GDP) and applicable quality system requirements.
• Identify nonconforming materials and initiate or support Material Review Board (MRB) activities for review and disposition.
• Utilize electronic Quality Management Systems (eQMS) and other electronic systems to document inspection results, nonconformances, and quality records.
• Compile, maintain, summarize, and analyze inspection and quality data using Microsoft Excel and other electronic systems to support investigations, supplier performance monitoring, and continuous improvement activities.
• Collaborate with cross-functional teams, including Engineering, Manufacturing, Supply Chain, and R&D, to resolve quality issues and support product and process improvements.
• Follow departmental Standard Operating Procedures (SOPs), Work Instructions, and established quality system requirements.

Incidental Duties: The above statements describe the general nature and level of work being performed and are not intended to be an exhaustive list of all responsibilities. Additional duties may be assigned by management as business needs require.

Job Requirements:

Education and Proficiency:

• High School Diploma or equivalent required; additional technical training or quality inspection experience preferred.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to communicate effectively with groups of employees within the organization.
• Ability to perform these functions in English.

Preferred Skills:

• Experience: One to three years of related experience and/or training, preferably in Medical Device, Pharmaceutical, Manufacturing, Quality, or other technical environment
• Computer Skills: Experience using electronic systems and software, including Microsoft Word and Excel. Ability to enter, maintain, organize, and analyze data using Excel. Experience with ERP systems (e.g., Oracle, SAP) and/or electronic Quality Management Systems (eQMS) is preferred.
• Math Ability: Ability to add, subtract, multiply, and divide using whole numbers, fractions, and decimals. Ability to interpret measurements and inspection data accurately.
• Technical Skills: Experience with inspection techniques and measurement tools (e.g., calipers, gauges, and other inspection equipment) preferred. Ability to read and interpret engineering drawings, specifications, inspection plans, and acceptance criteria. Ability to understand product functionality, assembly methods, test processes, and quality requirements.
• Reasoning Ability: Ability to apply sound judgment and follow detailed written and verbal instructions. Ability to evaluate inspection results, identify nonconformances, and make decisions within established procedures and quality standards.
• Abilities: Strong attention to detail and accuracy; effective verbal and written communication skills; ability to work independently and collaboratively in cross-functional teams; ability to utilize electronic systems to document quality records and support data collection, trending, and continuous improvement activities.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Employee is required to sit at a desk for long periods of time
• Frequently uses hands and fingers, occasionally reaches up/down with arms
• Position requires occasional standing and walking
• Position requires occasional bending and stooping
• The noise level in the environment is moderate
• PPE- Safety glasses required worn by all personnel in production areas or as indicated.