Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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 first article inspection (FAI) and 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
- Perform other related duties and responsibilities, as assigned.
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.
Qualifications
- Highschool diploma or equivalent.
- Must be able to read, write and otherwise communicate in English with sufficient fluency.
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.
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.
Ambu Provided Training Within The First Six Months
- According to area specific training plan.