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Fenix Parts, Inc.

QC Specialist

Career Insights for Quality Control Analyst

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What they do

A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.

$53,614 / year median in Kentucky

-16% projected decline

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Job Description

About the
Role:
The QC Specialist plays a critical role in ensuring that products and processes meet established quality standards and regulatory requirements within the organization. This position is responsible for conducting thorough inspections, testing, and audits to identify any deviations or defects that could impact product integrity or customer satisfaction. The QC Specialist collaborates closely with production, engineering, and supply chain teams to implement corrective actions and continuous improvement initiatives. By maintaining detailed documentation and reporting, this role supports compliance with industry standards and internal quality policies. Ultimately, the QC Specialist helps safeguard the companys reputation by ensuring that only high-quality products reach the market.
Minimum Qualifications:
Bachelors degree in Quality Assurance, Engineering, Life Sciences, or a related field.

At least 2 years of experience in quality control or quality assurance within a manufacturing or production environment.

Strong understanding of quality control methodologies, statistical process control, and root cause analysis.

Familiarity with regulatory standards such as ISO 9001, GMP, or FDA regulations relevant to the industry.

Proficiency in using quality management software and Microsoft Office applications.
Preferred Qualifications:
Certification such as ASQ Certified Quality Auditor (CQA) or Certified Quality Improvement Associate (CQIA).Experience working in a regulated industry such as pharmaceuticals, medical devices, or food production.

Knowledge of Lean Six Sigma principles and experience applying them to quality improvement projects.

Advanced skills in data analysis and reporting tools.

Strong project management experience related to quality initiatives.
Responsibilities:
Perform routine and non-routine inspections and tests on raw materials, in-process components, and finished products to verify compliance with quality specifications.

Document inspection results by completing reports, summaries, and logs, and communicate findings to relevant departments.

Investigate quality issues, identify root causes, and recommend corrective and preventive actions to avoid recurrence.

Collaborate with cross-functional teams to support quality improvement projects and ensure adherence to regulatory and company standards.

Maintain calibration and maintenance records for quality control equipment and ensure all tools are functioning properly.

Assist in internal and external audits by preparing necessary documentation and facilitating audit activities.

Stay current with industry best practices, quality standards, and regulatory requirements to continuously enhance quality processes.
Skills:
The QC Specialist utilizes analytical skills daily to assess product quality and identify deviations from standards. Attention to detail is essential when performing inspections and documenting results to ensure accuracy and compliance. Communication skills are critical for effectively collaborating with cross-functional teams and reporting findings to management. Problem-solving abilities are applied to investigate quality issues and develop corrective actions that improve processes. Additionally, proficiency with quality management systems and data analysis tools enables the specialist to monitor trends and support continuous improvement efforts.