Quality Inspector I

INTEGRA LIFESCIENCES CORP; Plainsboro Township (NJ); On-site; USD 26,436 - 35,032; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) savings plan

Job summary

INTEGRA LIFESCIENCES CORP, located in Plainsboro Township, NJ, is seeking a Quality Inspector to perform essential inspections on components and products according to regulatory standards. Candidates should have strong organizational skills and preferably experience in the medical device sector.

The role requires a High School Diploma and knowledge of ISO13485. The position offers a salary range of $19.19 – $25.43 per hour and various benefits including medical, dental, and a 401(k) plan.

Qualifications

• QA experience in the medical device industry preferred.
• Working knowledge of ISO13485, 21CFR820 FDA QSR, and cGMP preferred.
• Ability to communicate in English (read, write, watch, speak).

Responsibilities

• Perform inspections using measuring and test equipment.
• Conduct first-article, incoming, and in-process inspections.
• Maintain accurate inspection records and reports.

Skills

Strong organizational skills

Problem-solving skills

Interpersonal skills

Attention to detail

Time-management skills

Education

High School Diploma

Tools

Microsoft Office Suite

Job description

SUMMARY DESCRIPTION

The Quality Inspector will perform quality assurance inspections on purchased components, manufactured sub‑assemblies, and final products in accordance with corporate policies, FDA regulations, ISO 9001, ISO 13485, and the Medical Device Directive.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform inspections using a variety of measuring and test equipment to determine acceptance or rejection of material or parts.
• Conduct first‑article, incoming/receiving, and in‑process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing.
• Interpret drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
• Read and interpret sampling plans as per ANSI.
• Assist in training new associates according to the Quality System Regulations and company SOPs.
• Maintain accurate and current inspection and/or testing records (Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, etc.).
• Assist with reviewing inspection reports, completed quality forms, logbooks, and associated documentation.
• Perform inspections in classified clean rooms as necessary.
• Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
• Maintain records of all testing performed on the appropriate test records.
• Assist in physically moving and labeling non‑conforming material and customer returned material, including rework, scrap, and return to vendor.
• Maintain the QC inspection areas in an orderly manner conducive to safe and efficient inspections and procedures.
• May also perform other related duties, responsibilities, and special projects as assigned.

DESIRED MINIMUM QUALIFICATIONS

• High School Diploma.
• QA experience in the medical device industry preferred.
• Strong organizational skills, self‑directed, strong problem‑solving and interpersonal skills.
• Working knowledge of ISO13485, 21CFR820 FDA QSR, and cGMP preferred.
• Knowledgeable 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.
• Ability to integrate quality objectives across multiple functions.
• Attention to detail and strong time‑management skills.
• Must be able to work independently with minimal supervision.
• Ability to communicate in English (read, write, watch, speak). The employee must repeatedly sit, listen, speak, and write in English.
• Required to enter clean rooms while adhering to standard operating procedures.
• May be required to lift and/or move up to 50 lbs periodically.
• Role requires passing a visual acuity test; vision aids are allowed and must be worn during inspections if needed.

AIR COMPENSATION & BENEFITS

Salary Pay Range: $19.19 – $25.43 USD Hourly.

Benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a 401(k) savings plan.

EEO STATEMENT

Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. For more information about your rights under the law, please see EEOIsTheLaw and EOE including Disability/Protected Veterans.

Integra LifeSciences is committed to providing qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email [e-mail].