Quality Technician

Position: Quality Technician I
JOB SUMMARY:

The Quality Technician is responsible for supporting the Quality Management System (QMS) in compliance with FDA regulations (21 CFR Part 820, and Part 11 as applicable) ISO 13485 and 9001 standards, and internal procedures. This role ensures timely execution of quality-related activities including documentation review, nonconformance processing, environmental monitoring, calibration tracking, and data integrity support.

The Quality Technician plays a critical role in maintaining inspection readiness, supporting audits, and ensuring product quality and regulatory compliance.

Quality System Support Assist in maintaining compliance with industry regulations and standards, GMP requirements, and internal procedures

Support internal and external audit readiness activities

Participate in internal audits and assist in audit response and closure

Documentation & Record Management Review and ensure completeness of quality records and production documentation

Support timely closure of records in accordance with ALCOA+ data integrity principles

Maintain organized and inspection-ready documentation systems

Nonconformance & MRB Support Initiate, track, and assist in the investigation of Nonconformance Reports (NCRs)
Support Material Review Board (MRB) activities and documentation

Ensure timely closure of quality events and proper documentation of dispositions

Calibration & Equipment Control Track calibration schedules and maintain calibration records

Coordinate calibration activities with internal teams and vendors

Ensure equipment is compliant and within calibration requirements prior to use Cleanroom & Environmental Monitoring Support routine monitoring of cleanroom conditions (e.g., particulate, temperature, humidity, pressure differentials)
Review and trend environmental data for compliance

Support investigation and documentation of environmental excursions

Ensure proper documentation and monitoring of controlled environments

Assist in identifying and escalating environmental deviations

Change Control Support Assist in initiating and tracking change control requests

Ensure required documentation and approvals are completed

Support implementation and closure of change controls

Supplier Quality Support Assist in maintaining supplier qualification records

Support incoming inspection and supplier performance monitoring

Track supplier corrective actions and documentation

Software Validation & Data Integrity Support validation documentation for GxP software systems (e.g., IQ, OQ, PQ)
Perform routine audit trail reviews and support data integrity initiatives

EDUCATION:

Associate’s or Bachelor’s degree in a scientific, engineering, or related field preferred

Experience1–3 years of experience in a regulated industry (FDA, GMP, medical device, or pharmaceutical preferred)

Experience with Quality Systems and documentation practices

Skills & Competencies Knowledge of FDA regulations (21 CFR Part 820, QSMR)
Strong attention to detail and organizational skills

Ability to manage multiple tasks and meet deadlines

Familiarity with quality systems such as CAPA, NCR, and change control

Proficiency in Microsoft Office and quality management software systems

Strong written and verbal communication skills

Working Conditions Involves work in cleanroom or controlled environments

Use of PPE as required

Occasional cross-functional collaboration with Operations, Engineering, and Quality teams

Key Performance Indicators (KPIs)
On-time closure of quality records (NCRs, MRBs, change controls)
Calibration compliance rate Environmental monitoring compliance

Audit readiness and documentation accuracy

Reduction in backlog of quality system records

WORKING CONDITIONS:

Works under general supervision while learning new concepts quickly. Requires light physical activity performing non-strenuous daily activities.

Must be able to lift up to 25 lbs.

Must be able to sit or stand for long periods of time

Must be able to climb up and down stairs

Travel is required to support company initiatives

NOTE:

This job description is not intended to be an exhaustive list of all possible duties, responsibilities and/or qualifications. Other duties, responsibilities and/or qualifications may be assigned to this position.
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