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Quality Technician jobs in United States
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Optos · 3 hours ago

Quality Technician

Optos is a company focused on quality assurance in the medical device sector, and they are seeking a Quality Technician to apply quality assurance and regulatory principles. The role involves maintaining records, ensuring the effective operation of the Quality Management System (QMS), and approving equipment for shipment.
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Comp. & Benefits

Responsibilities

Coordinate and maintain calibration of tools and equipment for all in-house and field technicians with external calibration supplier
Maintain Device History Records for the purpose of product release. For internal and external manufacturing activities
Maintain MRB material flow and keep records systematically
Perform inspections of parts and keep records as needed by Quality/ Engineering function
Filing and maintenance of Service Records and Customer Files
Prepare daily and monthly compliance reports for quality, operations and customer support
Participate in the completion of internal audits
Assist in document control activities
Assist in preparation for third party audits
Perform inspections of modules at supplier sites
Provide support to the Manager QA/RA-North America for any tasks relating to the quality system and regulatory requirements

Qualification

Calibration of ToolsFirstSecond Party AuditsISO 13485 Internal AuditingQuality Assurance ExperienceMedical Device ExperienceLean Six Sigma CertificationComputer SkillsAttention to DetailOrganizational Skills

Required

Experience with Calibration of Tools and Equipment
Experience performing first and second party audits
Ability to produce high quality work under pressure and within tight timescales
An ability to work within tight deadlines and manage time effectively
Strong team player with flexible attitude to work priorities
Excellent computer skills (MS Office applications)
Highschool graduation minimum, bachelors in any technical field or technical certification preferred

Preferred

Prior Quality Assurance Experience preferred
Lean Six Sigma White/ Yellow Belt a plus
Medical Device experience
Close attention to detail
Excellent organizational skills
ISO 13485 Internal Auditing training

Benefits

Eligibility for company bonus program.

Company

Optos

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Optos operates as a medical retinal imaging company.

Funding

Current Stage
Public Company
Total Funding
unknown
Key Investors
NHS England
2020-09-11Grant
2015-02-27Acquired
2006-02-15IPO

Leadership Team

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Robert Kennedy
Chief Executive Officer
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Quinn Lyzun
President, Americas
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Company data provided by crunchbase