Job Title: Quality Technician

Job Description

We are seeking a dedicated Quality Technician to participate in the design, creation, implementation, and monitoring of programs and methodologies to ensure that products meet established specifications, design criteria, quality standards, and customer requirements. This role offers a great opportunity for advancement in a growing company.

Responsibilities

• Review records for product release and documents for completeness and accuracy under a production schedule.
• Review and update (as authorized) quality system documentation.
• Log, file, maintain, and archive various QA reports and records.
• Track key performance metrics.
• Prepare and collect materials for the monthly Instrument & Reagent Quality Review meetings.
• Investigate and work with other departments to resolve quality issues related to assigned areas.
• Participate in internal compliance audits to ensure adherence to the Quality System Manual and applicable regulations and standards.
• Participate in continuous improvement efforts by completing corrective and preventive actions as assigned.
• Assist other Quality Assurance personnel in Material Review Board (MRB) activities as needed.
• Order non-inventory items for Quality Assurance.

Essential Skills

• Quality assurance
• Quality control
• Quality check
• Documentation review
• Knowledge of FDA regulations

Additional Skills & Qualifications

• Associate degree in a life science or engineering, or equivalent related experience.
• Experience in a Good Manufacturing Practices (GMP) environment preferred.
• 1+ years of experience participating in formal audits preferred.
• Minimum of 3 years’ experience in a manufacturing environment, previous quality experience preferred.

Work Environment

The position is based in a mid-sized manufacturing environment. Most of the day will be spent at a desk. Initial training will be conducted from 8 AM to 4:30 PM, after which the schedule will transition to approximately 10 AM to 6:30 PM.