Quality Technician I - 2nd Shift in Vineland, New Jersey at COMAR LLC

Quality Technician I - 2nd Shift 3:00pm-11:30pm

We are seeking a detail-oriented and diligent Quality Technician to join our team on the 2nd Shift , ensuring our products meet the highest standards of quality and compliance with ISO 9001 and ISO 13485 standards. This role offers an excellent opportunity to contribute to a quality-driven organization committed to continuous improvement and excellence in manufacturing.

Key Responsibilities:

• Perform first piece and daily visual and dimensional analysis of finished products at specified intervals according to inspection plans.
• Conduct first article inspections and evaluations to verify product conformity.
• Perform floor audits of paperwork, materials, finished products, and control plans as outlined in inspection schedules.
• Inspect non-conforming products, initiate containment activities, and execute control procedures for non-conforming items, documenting results accurately.
• Collaborate with team members to ensure all required quality checks and tasks are completed daily.
• Escalate issues or non-conformances promptly to the Lead Quality Inspector for resolution.
• Maintain accurate records of inspections, audits, and non-conformance reports in compliance with ISO standards.

Skills and Abilities:

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure materials
• Ability to work independently and in a team environment
• Skilled at learning the use of equipment for dimensional analysis
• Detailed-oriented/capability of discovering nonconformances in both paperwork and materials
• Ability to apply basic math skills: add, subtract, multiply, divide. Compute rate, ratio, percent.
• Ability to carry out instructions provided in written, oral, or visual/diagram format.
• Ability to communicate their job related functions with other employees, cross-department, with customers and auditors as needed.
• Ability to interact with manufacturing associates in a meaningful way to ensure collaboration

Physical Demands

• Stand and walk for the most of the work shift
• Use hands and fingers to handle or feel; reach with hands and arms; crouch, stoop, kneel, and only occasionally sit
• Lift/move up to 25 pounds. Heavier items can be moved with assistance of equipment
• Use close, color and peripheral vision, depth perception, and adjust focus.

Work Environment

• The noise level in the work environment is usually loud
• Employee with regularly operate in an ISO environment

Basic Qualifications

• High School Diploma or General Education Degree (GED)
• Have 0-1 Years Experience in Quality Control or in a GMP Manufacturing Environment
• Understanding of computers and software
• Understanding of Statistical Process Control (SPC) tools and techniques.
• Understanding of Gauge Repeatability and Reproducibility (Gauge R&R)

Preferred Qualifications

• Bachelor's Degree for Science, Technology, Engineering or significant applicable experience, training, and certifications
• Experience working in medical device, pharmaceutical, or food manufacturing environments
• Experience with visual inspection standards and processes
• Experience working in an ISO or regulated environment
• Experience working in a cleanroom environment