Quality Control Inspector II

Integra LifeSciences Holdings Corp.•Braintree, MA

76d•$21 - $28

About The Position

The Quality Control Inspector II will be responsible for performing quality inspections and testing according to established procedures. Inspection and testing activities will cover incoming, work-in-process, and finished goods. Selects random samples for tests at specified stages such as incoming or in production process, and tests products for variety of qualities, such as dimensions, performance, appearance, correct assembly, and other testing outputs. Records test data, applying statistical quality control procedures. Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Performs the essential duties and responsibilities listed in section below.

Requirements

High School Diploma or equivalent with 1+ years of experience 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.
Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
Working knowledge of standard laboratory practices and safety.
Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
Detail-oriented.

Responsibilities

Perform chemical assay of solutions as well as general laboratory maintenance.
Performs in-process and final inspection of all products for conformance to specifications.
Maintains and records quality testing information as part of a DHR (Device History Record).
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.
Inspection and testing of raw materials, intermediates and recording of test results.
Maintains a working inventory of all components and archived materials and solutions.
Assist as needed in test method validation, implementation, and execution.
Provide database support, generate reports and analyze process data.
Assist in Out of Specification (OOS) and non-conformance (NC) investigations.
Assist in preparing for and participating in FDA audits, customer audits, etc.
Demonstrate excellent organizational and time management skills.
Demonstrated competency of MS Suite.
Perform other duties as required.