QA Inspector

ARCH•Emerson, NJ

5h•Onsite

About The Position

The QA Inspector is responsible for ensuring the quality and integrity of products by performing various inspection and testing procedures. This role involves meticulous documentation, adherence to strict regulatory standards, and maintaining a clean and organized work environment. The inspector will also play a role in processing returns, handling complaints, and training new hires on quality procedures.

Requirements

High School diploma or equivalent
Requires great attention to detail and the ability to read drawings and specifications
Experience using calipers and micrometers
Ability to read and comprehend simple instructions, short correspondence, and memos.
Ability to write simple correspondence.
Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
Ability to deal with problems involving a few concrete variables in standardized situations.
Regularly required to stand, walk, and use hands to finger, handle or feel objects, tools or controls.
Frequently required to talk and hear and occasionally to reach with hands and arms and stoop, kneel, crouch, or crawl.
Must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, peripheral vision, depth perception and the ability to adjust focus.
Attendance/Punctuality - Is consistently at work and on time.
Dependability - Follows instructions, responds to management direction.
Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure quality.
Safety and Security - Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properly.

Responsibilities

Receive, unpack, and verify count of products and condition of receipt
Inspect incoming materials and finished goods to technical drawings or product specifications by performing dimensional measurements, function tests and pattern assessments
Document inspection results by inputting data into quality database, completing forms and logs, summarizing inspection findings and rejecting non-conforming material
Laser mark and electro chemical etch, neutralize and clean products
Process product returns and complaints, including evaluation of quality issues and initiating repairs or reworks as needed
Ensure the company’s products comply with all FDA regulations, prepare submissions and maintain regulatory databases
Adhere strictly to all CGMP, FDA 21 CFR820, ISO 13485, EU MDR and company procedures to ensure the quality and integrity of the products and safety of the workplace
Keep Quality area organized and clean
Keep stock of Quality materials such as tip protectors, test materials, etc.
Conduct training on receiving and inspections and orientation for new hires
Maintain commitment to Quality Goals and Quality Policy
Complete jobs and tasks as assigned
Must be able to work in a team environment