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CooperCompanies · 1 month ago

Validation Specialist (6 months contract)

711 North Road, Scottsville, NY, 14546, US

Full-time, Contract

Onsite

Entry, Mid Level

$56K/yr - $93K/yr

2+ years exp

CooperVision is a company focused on quality management in the medical device industry, and they are seeking a Validation Specialist to assist in validation and testing tasks. This role will support MDR remediation activities and ensure compliance with both domestic and international quality standards.

Medical Device

Responsibilities

Tests systems and implements validation packets

Validates and qualifies equipment for use in manufacturing and quality control testing of products

Assists in drafting validation protocols and reports, as well as developing written maintenance procedures

Identifies and documents potential gaps based on validation tasks performed

Conducts validation exercises for technology and manufacturing systems to support in-line products and processes at manufacturing sites

Performs validation of process equipment installation, operational, and performance qualification studies to assess functionality

Executes operational qualification assessments to ensure critical operating parameters are within qualified parameters

Implements equipment enhancements as directed to support intended qualified operational ranges

Documents deviations and/or investigations related to remediation activities

Qualification

Validation testingStatistical process controlExcel proficiencyTechnical report writingMedical device experienceWord proficiencyPowerPoint proficiencyMathematicsScience degreeProblem-solving

Required

Ability to write technical reports and correspondence

Ability to use statistics and mathematics

Ability to solve practical problems and deal with a variety of concrete and abstract variables in situations where only limited standardization exists

Minimum of 2–5 years of experience in performing quality validations within a manufacturing environment

Proficient in validation testing and development of statistical process control and monitoring

Associate Degree or Technical Studies preferably related to the fields of Engineering or Science

Preferred

Advanced skill in the use of Excel, Word and PowerPoint

Previous experience in the medical device industry

Company

CooperCompanies

CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.

Founded in 1958

San Ramon, California, US

10001+ employees