QA Technician

StatLab; McKinney (TX); On-site; Full time

Job summary

Une entreprise leader dans les solutions de diagnostic recherche un spécialiste en assurance qualité pour rejoindre son équipe à McKinney. Le candidat idéal aura un diplôme en sciences de la vie, ainsi que deux ans d'expérience en assurance qualité, avec une solide capacité à documenter les processus. Vous travaillerez en étroite collaboration avec les équipes pour garantir que les produits répondent aux normes les plus strictes, tout en maintenant un environnement de laboratoire propre et efficace.

Benefits

Avantages compétitifs

Environnement de travail axé sur l'équipe

Qualifications

• Expérience de 2 ans ou plus en assurance qualité et documentation.
• Expérience préalable en laboratoire considérée comme un atout.
• Capacité à parler, lire et écrire en anglais couramment.

Responsibilities

• Effectuer des inspections des matières premières et des produits finis.
• Préparer des échantillons et effectuer des tests analytiques.
• Maintenir un environnement de laboratoire sûr et organisé.

Skills

Communication écrite efficace

Précision

Analytique

Compétences en documentation technique

Collaboration

Education

Bachelor’s Degree in life sciences or chemistry

High school diploma/GED with relevant experience

Job description

Job Details

Description

Duties and Responsibilities

• Perform incoming raw material inspections and finished good inspections.
• Utilize instrumentation (FTIR, gage, torque meters) as needed to perform identification of materials and perform dimensional checks to ensure they are within tolerance.
• Prepares samples and conducts analytical testing such as titration, pH, pipetting, assays, etc.
• Establishes and maintains a safe, clean, and organized laboratory environment using good laboratory practices and 5S.
• Approves incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.
• Approves in-process production by confirming specifications; conducting visual and measurement tests; communicating required adjustments to production supervisor.
• Approves finished products by confirming specifications; conducting visual and measurement tests; returning products for re-work; confirming re-work.
• Documents inspection results by completing reports and logs; summarizing re-work and waste; inputting data into quality database.
• Keeps measurement equipment operating by following operating instructions; calling for repairs, ensuring calibration is current.
• Maintains safe and healthy work environment by following standards and procedures, complying with legal regulations.
• Updates job knowledge by participating in educational opportunities; reading technical publications.
• Accomplishes quality and organization mission by completing related results as needed.
• Develops and executes QA program to ensure conformity of purchased material and manufactured products to specified customer and company standards.
• Continuously improves quality management execution and stays knowledgeable regarding equipment maintenance and utilization in the execution of manufacturing activities.
• Implements and continuously improves inspection methods for receiving, in-process and finished goods.
• May analyzes quality trends as assigned to identify opportunities for improvement, need for corrective action, and to anticipate potential delays or defects.
• Provides analytics to support supplier management and supplier qualification programs.
• Resolves quality issues collaboratively with colleagues, suppliers, and customers.
• Executes quality management system documentation to meet or exceed ISO13485 and 21CFR requirements.
  
  

Requirements

• Bachelor’s Degree in life sciences, chemistry preferred, or related field with equivalent experience. Will consider high school diploma/GED with applicable experience.
• Two or more years experience in quality assurance/documentation.
• Previous Lab experience is strong asset.
• Experience in writing technical documentation, procedures, and work instructions.
• Ability to examine documents for accuracy and completeness.
• Fluently speak, read, and write English.
• Effective written communication skills.
• Demonstrated ability to effectively speak in front of groups of co-workers and vendors.
• This position needs to be onsite in our McKinney facility.
  
  

We offer competitive pay, great benefits, and a fantastic, team-oriented environment. StatLab's Core Values of Caring, Doing, and Delivering ensure our products ensure we are delivering the best patient care through our diagnostic solutions.

Please submit your resume and salary requirements.

Please no phone calls and no recruiters.

There is no relocation available for this position.

StatLab Medical Products is an equal opportunity employer. This position starts at $18.94 per hour and is onsite in our McKinney facilities.

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