Quality Control Technician
About The Position
The Quality Control Technician works within the Quality Department and in-house manufacturing to support quality-system compliance and continuous improvement. The role oversees and participates in developing, documenting, monitoring, and maintaining quality systems to ensure conformance with regulatory requirements and company policies and procedures throughout the manufacturing process. The position performs quality testing and inspections, supports equipment qualification and calibration activities, monitors controlled manufacturing environments, reviews production and sterilization records, and identifies non-conformances and improvement opportunities. The technician also supports company compliance obligations and represents the company professionally and ethically in interactions with employees, customers, suppliers, and other third parties. Other duties may be assigned as necessary.
Requirements
- At least 2 years of experience in Quality Control.
- Knowledge of Microsoft Word, PowerPoint, and Excel.
- Strong typing, analytical, problem-solving, communication, and writing skills.
- Ability to work as a flexible team player in a deadline-dictated environment.
Nice To Haves
- Bachelor’s degree preferred.
- Knowledge of GMP regulations preferred.
Responsibilities
- Perform quality control testing on manufacturing supplies, in-process materials, and finished products, including DBM, residual moisture, and peel testing as needed.
- Perform in-process and final product inspections.
- Draft test reports for tests performed.
- Participate in qualification of new manufacturing equipment.
- Perform viable and non-viable particulate environmental monitoring in cleanrooms.
- Monitor temperature, pressure, and humidity in controlled environments.
- Identify non-conformances and areas for improvement.
- Inspect and approve product labeling.
- Help coordinate facility equipment calibrations and preventative maintenance.
- Review cleaning logs and steam and ETO sterilization runs.
- Complete personnel environmental monitoring.
- Participate in continuous improvement functions and implement changes.
- Review processing records, test results, certifications, and related materials as needed.
- Perform other duties and responsibilities as necessary.
- Adhere to the company Code of Conduct, AdvaMed Code, MedTech Code, and other company policies.
- Support compliance with applicable governmental laws, rules, and regulations by completing introductory and annual training and maintaining role-related compliance knowledge.
- Represent the company professionally and uphold ethical business practices and socially responsible conduct in interactions with employees, customers, suppliers, and other third parties.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
