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NextBeam · 4 days ago

QA Lead & Site Supervisor

Cleveland, OH

Full-time

Onsite

Mid, Senior Level

$90K/yr - $110K/yr

3+ years exp

NextBeam is a company focusing on quality management and site supervision, and they are seeking a QA/Site Supervisor responsible for overseeing quality control processes and site operations. The role involves ensuring compliance with industry standards, managing laboratory testing, and leading a small onsite team to fulfill customer obligations.

Dietary SupplementsManufacturingMedicalMedical Device

Hiring Manager

Andrew Patton

Responsibilities

Establish and maintain good technical understanding of relevant industry standards and regulations (ISO 13485, ISO 11137 series, ISO 11737 series, ASTM 51649, ASTM 52303) in order to design and perform testing with appropriate test methods, sample sizes, statistical techniques, and acceptance criteria

Collect, analyze, and report data to release / reject product batches and other studies

Maintain calibration of laboratory equipment and tools

Investigate, root-cause analyze, and provide disposition when quality events occur

Maintain document control including developing new and updated procedures, forms, templates and recordkeeping systems

Support audits by customers, regulators, and other groups including understanding and communicating how we meet applicable requirements, planning and implementing corrective actions

Maintain a high level of quality and integrity even under challenging conditions such as undesirable test results or during customer or regulatory audits

Collaborate with other functions to convey the importance of quality control including how quality control affects and is affected by other functions

Schedule, prioritize, and communicate status of testing according to a variety of factors including internal, customer, and compliance requirements

Maintain inventory of lab supplies and consumables

Maintain accuracy and completion of sample inventory and other logs

Assist with data trending and analysis for monitoring validated processes and supporting changes when necessary

Assist with establishing schedule and responsibilities for lab personnel to drive customer and employee satisfaction

Participation in industry standards development and updating internal documentation for continuing compliance as standards and regulations are revised

Understand and be able to operate NextBeam’s Enterprise Resource Planning (ERP) system to receive, work order, and invoice jobs

Maintain strong and proactive communication with our onsite manufacturing partner

Assure that the small (1-3 person) onsite NextBeam team is trained and organized

Provide first-line guidance to help junior staff perform their designated tasks

Assure NextBeam meets its obligations to customers in conjunction with our Customer Service team

Qualification

Quality ControlISO StandardsStatistical AnalysisMicrosoft OfficeDocument ControlCalibrationAAMI CISS-RADMathematicsCommunication SkillsTeam Leadership

Required

College diploma or equivalent

3+ years in quality control or a related function

Ability to communicate with native or bilingual proficiency in English including reading, writing, listening, and speaking in a professional and technical manner with internal and external groups

Very strong skills with Microsoft Office applications (Word, Excel)

Ability to lift 30lbs., sit or stand for long periods of time

Strong skills in mathematics and statistics

Bachelor's (Required)

Quality Control: 3 years (Required)

Management: 2 years (Required)