Senior Quality Control Inspector

Integra LifeSciences•Braintree, MA

13d•$23 - $31

About The Position

The Sr. Quality Inspector is responsible for supporting Quality Control Incoming Inspection and Review & Release activities to ensure compliance with internal procedures, regulatory requirements, and quality standards. This position serves as a key technical resource within the Quality Control organization, providing support for incoming material inspection, batch record review, product release activities, non-conformance investigations, and continuous improvement initiatives. The role works collaboratively with Manufacturing, Engineering, Quality Assurance, Supply Chain, and other cross-functional groups to support daily operations and maintain operational efficiency. This position is expected to operate flexibly between QC Incoming Inspection and Review & Release functions based on business needs, workload demands, and organizational priorities while ensuring compliance and product quality. Perform the essential duties and responsibilities listed in section below.

Requirements

High school diploma or equivalent with 5 years of experience
Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
Knowledge of QC terms, tools, and methodologies.
Working knowledge of standard laboratory practices and safety.
Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
Detail-oriented.

Nice To Haves

A bachelor’s degree or associate degree in a related field is preferred.
Related work experience is preferred in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated industry.
Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.

Responsibilities

Supports QC collaboration with Quality Management to ensure all quality standards are met, including but not limited to inspecting reports are properly updated and completed in a timely manner.
Inspects products, processes, and systems to ensure compliance with quality standards.
Assists in investigating non-conformances, identifying root causes, and implementing corrective actions.
Supports documentation and reporting quality control findings and the analysis of data to recommend process improvements.
Supports Review & Release activities including review of manufacturing, inspection, and quality records to ensure completeness, accuracy, and compliance with established procedures.
Supports Inspection and testing raw materials, intermediates and record test results. Assist as needed in test method validation, implementation, and execution.
Assists in training employees in quality standards, KPIs and procedures.
Assists with the implementation of new or improved quality control systems as needed.
Supports maintaining a working inventory of all department components, materials and solutions.
Ability to assist in root cause analysis and implement corrective actions.
Serves as an informal resource for colleagues with less experience.
Collaborate with Quality Management to ensure compliance with industry regulations, company policies, and safety standards during the transition process.
Provides database support with generating reports and analyzing process data.
Support Quality Management in preparing for and participating in FDA audits, customer audits, etc.
Maintains work areas and equipment in a clean and orderly condition.
Must be able to work in a Team environment, multi-task and communicate effectively.
Demonstrate excellent organizational and time management skills.
Knowledge of industry standards and regulations related to quality control.
Perform other duties as required.