Quality Control Inspector (plastics injection molding)

This position is responsible for performing in-process, component and finished goods visual and dimensional inspections using SPC/AQL sampling plans to support production, incoming receiving inspection and Quality investigations as needed. These inspections utilize industry standard metrology and gaging methods to identify defects and ensure product meets customer requirements. This position works on the production floor sampling, performing visual inspections and assessing quality of the parts and process. Attention to detail and the ability to work with minimal amount of supervision and understanding of quality inspection tools and equipment is required.

Essential Job Functions and Responsibilities:

• Perform dimensional and visual In-process and finished good inspection on parts/boxes per approved control plans, test methods and customer drawings.
• Quality / SPC evaluation when required per site documentation.
• Communicate with Machine Technicians, Operators and Production Supervisors inspections/SPC results to operation when defects are detected to ensure process adjustments are made and in an effort to run a consistent quality product.
• Review daily NCR reports, SPC charts and quality system documentation.
• Enforce and maintain our Quality System and provide suggestions to maintain our continuous improvement system.
• Visually and dimensionally evaluate product and packaging in accordance with established acceptance criteria and standards.
• Follow all Safety rules and guidelines. Report any unsafe condition or practice.
• Maintain a clean work area throughout the shift.
• Evaluate product documentation for adequacy and completeness.
• Visually and dimensionally evaluate product and packaging in accordance with established acceptance criteria and standards.
• Measure process performance against established acceptance criteria and standards.
• Record real time data and prepare formal reports.
• Other assignments as may be given by the Quality Engineer or Managers.
• Support maintenance and calibration requirements for Quality Lab and production floor
• Place non-conforming product on hold and create non-conforming records and assist with Quality inspections of rework product as needed.
• Partner with Quality Control department for the management of product retains.
• Update Quality Inspection requirements
• Assist in the creation, closure review and verification of completion of batch records and release products and issuance of certificates of compliance to ensure product produced meet the customer and regulatory requirements
• Assist with New Product validation as required.
• Participate in Gage Repeatability and Reproducibility (GR&R), Geometric Dimensioning and Tolerancing (GD&T or GD and T) Intermedium studies and product/process validations
• Review and release product for shipping though issuance of COC ensuring all Customer requested documents are provided at the time of shipment
• Maintain cleanliness of QC lab, implement and sustain 6S, Quality boards and speak to status of site Quality metrics
• Able to generate and reconcile Labels (as needed)
• Perform Environmental monitoring activities according to site procedures. Train Quality personal on environmental monitoring activities and clean room requirements.
• Other assignments as may be given by the Quality Supervisor or Plant leadership team.

Core Competencies:

• Statistical Process Control Knowledge
• Cosmetic, visual and dimensional Inspection
• Housekeeping
• General Safety
• Communication & Teamwork Skills
• Computer literate. Good verbal and written communication skills.
• Ability to perform standard measurement and test equipment.
• Attendance-dependability
• Time Management
• IQMS Knowledge
• Inspection Skills
• Organizational Skills
• Basic math skills
• Metrology
• Blueprint Reading
• Data Entry Skills

Knowledge, Skills, and Abilities

• Read and write in the English language.
• Must be able to perform basic math such as addition, subtraction, multiplication, division, fractions, and decimals.
• Ability to read and interpret basic engineering drawings and product specifications.
• Proficiency with utilizing ANSI Sampling Plans
• Proficient in utilizing hand measurement tools (Caliper, Micrometer, Ruler, Gage Blocks, etc.)
• Experience with PCDMIS and Measuremind 3D automated inspection software usage (CMM, OGP, Smart scope, etc.) and programming a plus
• Knowledge of Medical device standards and Regulations (ISO 13485)
• Ability to read and decipher blueprints
• Knowledge of GD&T
• Experience with handling non-conforming material
• Experience with device history record creation and review
• Knowledge of ERP and quality system elements
• Proficiency in using Microsoft Excel, Access Database and Word
• Experience in supporting process validation activities including testing and Gage R&R
• Knowledge of sample plans creation is a plus
• Understanding of risk management is a plus

Education and/or Experience :

• High School Diploma or GED.
• Minimum 6 months factory related experience in a regulated industry.
• Minimum of one year experience in visual and dimensional evaluation of molded products; or minimum three years experience in plastic injection molding and assembly processes
• Experience with calipers and micrometers is required; Other inspection equipment such as indicators, height gage, & pin gauges are a plus.
• Should have prior experience in a manufacturing environment to understand normal safety requirements.
• Certified Quality Inspector or Technician a plus