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https://www.hirelevel.com/
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25.00
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Quality Assurance Specialist
Posted: 12/06/25
2025-12-06
2026-01-05
Industry: Quality Assurance Specialist
Job Number: 133232
Pay Rate: 25.00
Job Description
HireLevel is hiring Quality Technician in Earth City, MO.
The Quality Technician is responsible for ensuring compliance with Quality System requirements. Areas of focus are process and equipment management, process improvement, and failure investigation.
Our client is a worldwide supplier of emergency medical products, respiratory products and medical gas construction equipment. We are a leading manufacturer of Ventilators, Carbon Dioxide Absorbents, Suction Regulators/Aspirators and Medical Gas Systems for hospital and patient care in home or emergency situations.
Job Category: Full-Time
Location: Earth City, MO.
Compensation: $25/hr.
Benefits once hired include:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Responsibilities of Quality Technician:
- Support in the implementation of process controls, NCRs, Product Returns/Rejects/MRB, Calibration system, and CAPA systems designed to meet or exceed internal and external requirements.
- Must be able to complete in-house gage calibrations along with managing calibration outsourcing activities. Managing equipment files, upkeeping equipment in a calibrated status, and driving improvements in gage use through the inspection/test process.
- Support and lead efforts of Gage Repeatability and Reproducibility (Gage R&R) and Test Method Validation with manufacturing engineers
- Support Quality Inspection Plan updates and equipment evaluation for suitable use on product parameters
- Must be able to manage product returns, lead Material Review Board activities
- Manages timelines for product and equipment investigations to ensure that reporting is performed on time, technical investigations are addressed in a timely manner, and corrections/corrective actions are performed.
- Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements
- Communicates product compliance and process expectations to the manufacturing floor. Creating work instructions, inspection plans/guides, and monitoring product concerns from manufacturing
- Support in the Change Control process with Technical Protocols, Reports and testing data to support changes being made. Including full Validation and Verification plans and completion.
- Work with process owners to create or update procedures and work instructions to address quality risks.
Essential Skills include:
- Support internal and external audits by showing compliance with processes owned Organization
- Strong written and verbal skills
- Collaboration skills
- QA process skills
- Computer knowledge and skills
Desirable Skills include:
- eQMS skills
- Knowledge of ISO 13485, MDSAP, 21 CFR 820, MDR 2017/745
- Quality engineering (ASQ or similar Certifications)
Essential Experience:
- Associates or Bachelors. Degree in an Engineering field is preferred (mechanical preferred).
- 1 - 3 years’ experience in regulated medical device industry highly preferred.
- Strong familiarity with calibration methods/standards, various gage use, and failed equipment risk analysis.
- Strong knowledge of global Quality System regulations related Good Manufacuting Practices. (ISO 13485, 9001, 17025)
- Legally authorized to work in the United States.
Desirable Experience:
- Professional certification(s) relevant to the position preferred (e.g., CQA, CQM, and/or CQE).
- Experience with electronic quality system documentation management and statistical tools such as GageTrak, MiniTab, Solidworks, CAD, PowerBI, Windchill, SAP, QPulse,etc.
- Excellent written and verbal communication skills.
- Project leadership skills.
- Experience with quality inspection processes and equipment
- Knowledge of safety requirements and legal standards
Who is HireLevel?
HireLevel is not just your average HR solutions company; we're the wizards of recruitment, payroll, and all things HR. Whether you're looking for a temp to hire, aiming for direct hire, or want to explore your options, we've got the path for your career success!
At HireLevel, we’re dedicated to supporting our employees’ well-being and work-life balance. We offer a comprehensive benefits package, including health insurance options and paid time off, to ensure you have the resources you need to thrive both personally and professionally.
Join our team and experience a workplace that values your growth, health, and future! Apply now at https://jobs.hirelevel.com/.
HireLevel is an equal opportunity employer.
HireLevel St. Louis: 3016 Locust St. In St. Louis, MO. 63103
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Login to save this search and get notified of similar positions.About Earth City, MO
Discover exciting job opportunities in the thriving area surrounding Earth City, Missouri! Nestled in a prime location near St. Louis, Earth City boasts a vibrant community with endless growth possibilities. Home to the stunning riverside beauty of Creve Coeur Lake Park and the renowned Hollywood Casino Amphitheatre, this area offers a perfect blend of green spaces and cultural attractions. With top-notch dining options including the famous St. Louis-style BBQ and a vibrant arts scene featuring galleries like the Foundry Art Centre, working in Earth City means immersing yourself in a world of culinary delights and creative inspiration. Don't miss out on the chance to advance your career while enjoying the charm and endless opportunities of this dynamic region!