Quality Inspector I, 2nd Shift

About the role

The Quality Inspector I will perform quality assurance inspections on purchased components, manufactured sub-assemblies, and final product in accordance with corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and other applicable regulatory agencies. This role requires familiarity with measuring critical dimensions and working within classified clean rooms as necessary.

Responsibilities

• Perform inspection using various measuring and test equipment to determine acceptance or rejection of material or parts.
• Conduct first article, incoming/receiving, and in-process inspections; determine acceptance or rejection after inspection and/or testing.
• Interpret drawings, specifications, charts, procedures, and other data to assess material acceptability.
• Read and interpret sampling plans per ANSI standards.
• Assist in training new associates according to Quality System Regulations and company SOPs.
• Maintain accurate inspection and testing records, including Material Certifications, Inspection/Test Results, Certificates of Conformance, and Rejection reports/tags.
• Review inspection reports, completed Quality forms, logbooks, and associated documents.
• Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during production.
• Maintain records of all inspections and testing on appropriate test records.
• Assist in moving and labeling non-conforming material, customer returns, rework, scrap, and return-to-vendor items.
• Maintain QC inspection areas in an orderly and safe condition.
• Perform other related duties, responsibilities, and special projects as assigned.

Requirements

• High School Diploma.
• QA experience in the medical device industry preferred.
• Strong organizational, problem-solving, and interpersonal skills.
• Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to work effectively in a cross-functional environment and integrate quality objectives across multiple functions.
• Strong attention to detail and time management skills.
• Ability to work independently with minimal supervision.

Physical Requirements

• Must repeatedly sit, listen, speak, and write in English.
• Required to move throughout all areas of the company and enter cleanrooms while adhering to Standard Operating Procedures.
• May periodically lift and/or move up to 50 lbs.
• Must pass a visual acuity test; vision aids (e.g., glasses, contact lenses) are allowed and must be worn during inspections if needed.

Pay

Salary pay range: $19.19 - $25.43 USD hourly. Individual pay is determined by job-related skills, experience, and relevant education or training. Eligible for bonus, commission, equity, or other variable compensation.

Benefits

• Medical, dental, and vision insurance.
• Life insurance, short- and long-term disability, and business accident insurance.
• Group legal insurance.
• Savings plan (401(k)).