Operator, Quality Control - 1st Shift

Objective:
The objective of this position is to perform quality inspections of products and components as specified.
Responsibilities and Essential Functions (applicable to all positions listed above):

• Perform and document required quality checks and inspections, including AQL (Acceptance Quality Level) sampling, as specified and as required.
• Ensure product traceability is maintained throughout the inspection sampling process.
• Develop a thorough knowledge of inspection criteria associated with applicable areas.
• Perform QC Hold activities (labelling nonconforming product).
• Perform sort and rework inspection activities on product as specified.
• Collect and provide pertinent information necessary for NCR's.
• Understanding of the partial release process in extrusion.
• Support the onboarding and training of new QCs to the Quality Team.
• Responsible for passing the yearly re-certification process within three attempts.
• Responsible for appropriately escalating quality issues to the NCR Response Team (NRT).
• Support with addressing needed GDP corrections on DHR packets, tracking DHR packets, and making DHR corrections as instructed by a QA.
• Follow all cGMP procedures.
• Responsible for documenting the DHR (Device History Record) accurately and legibly.
• Responsible to work in a way that prevents mix-ups, damage, deterioration, contamination, or other adverse effects to product during handling.
• Ensure all processing steps are performed in accordance with established work instructions and procedures.
• Ensure compliance with all environmental, health and safety regulations.
• Maintain a safe and clean workstation, facility, and common areas at all times.
• Communicate to the Leadership, any problem, idea, or solution which pertains to the Quality Department and/or its interaction with other departments.
• Utilize basic mathematical addition/counting principles and timekeeping.
• Responsible for utilizing proper Personal Protection Equipment (PPE) at all times.
• Responsible for following the gowning procedure and practicing good personal hygiene and health to prevent contamination of product and maintain product integrity.
• Ability to rotate to different production areas and perform quality inspections as needed to meet manufacturing needs.
• Ability to work overtime per company policy to meet production demand.
• Standing as needed for extended periods of time to perform assigned tasks
• All other duties as assigned by Lead or Supervisor.

Required Skills:

• Good attention to detail and organizational skills.
• Ability to read inspection gauges/instruments (e.g., tape measure, Go/NoGo gauges, calipers, etc.) and other measuring devices.
• Ability to follow directions and documented instructions.
• Ability to work independently in accordance with specifications and procedures.
• Ability to work well with others and communicate effectively.
• Ability to write legibly and perform written documentation in compliance with all document control procedures and GDP (Good Documentation Practices).
• Ability to distinguish tone and color.
• Ability to routinely lift, push, and/or pull up to 50 pounds.

Authorities:

• Stop production when product is not meeting the quality specifications.
• Refuse to perform activities independently in which training has not been completed and documented.
• Discard products into an approved scrap container that have been damaged, contaminated or do not conform to product specifications.
• Summon team leads, supervisors, and/or maintenance technicians as needed.
• Report safety, quality or other concerns on the line side or department boards and responsible personnel.

Work Environment:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.
Qualifications:

• Highschool diploma or equivalent.
• Must be able to read, write and otherwise communicate in English with sufficient fluency.

Job Type: Full-time