Job Description
Job DescriptionDescription:
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
Requirements:
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