Quality Assurance Manager

2 weeks ago

Saint Petersburg, United States Lenstec, Inc. Full time
Job DescriptionJob Description

Job Description

Quality Assurance Manager

Overview

As a Quality Manager, you provide overall guidance to site quality and operational teams on quality and regulatory requirements. Your planning skills will help in driving Inspection Readiness through continuous process improvement.

Through your comprehensive knowledge of quality and regulatory requirements, quality system management, product quality, process, and facility validation requirements, you will lead the site in Inspection Readiness preparation and facilitate improvements between different teams.

It is your problem-solving skills that will make our organization ready to achieve new milestones and help patients across the globe.

Responsibilities and Duties

  • Site representative for notified body and USA Regulatory inspections
  • Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
  • This role will work closely with production, quality systems, engineering, and operations.
  • Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people in inspection readiness.
  • Drive supplier qualification processes for all raw material at the site, assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and Certificates of Analysis.
  • Lead continuous inspection readiness for Quality Assurance.
  • Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
  • Ensure appropriate networking and sharing of best practices with different departments.
  • Responsible for site document control practices.
  • Review and disposition of any NC (non-conforming product).
  • Investigate and resolve customer complaints in a timely manner.
  • QA oversight to all areas including utility, manufacturing , laboratory and related computer systems.
  • Responsibility for the review of documentation related to validation activities as well as procedures, change controls, investigations, and action commitments.
  • Review/Approval of Device History Records from production.
  • Responsible for conducting and recording all training of site employees and reviews.

 

Required Qualifications

  • Bachelor’s Degree in Science or Engineering, equivalent experience will be considered.
  • 2-5 years of QA/RA experience in a medical device manufacturing environment.
  • Knowledge of ISO specifications, International regulations, FDA regulations, intraocular lens manufacturing and Quality Assurance and Quality Control Procedures.
  • Knowledge in related computer software, to include but not limited to, Internet Explorer, Microsoft Applications (Outlook, Word, Excel, Access, PowerPoint) and Adobe.
  • Ability to read and interpret literature pertaining to medical device manufacturing.
  • Medical Device manufacturing/Quality leadership experience.
  • Experience in Regulatory Inspections.
  • Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes.
  • Proactive approach and strong critical thinking skills.
  • Strong collaboration, relationship management, and interpersonal skills
  • Excellent written and verbal communication.

 

Preferred Qualifications

  • Advanced computer skills in MS Office applications and knowledge of quality systems analysis tools, such as risk analysis, Cpk , Quality Tracking, Trending, Document platforms

 

Company DescriptionAbout Lenstec
Lenstec, Inc. is a Florida-based medical device corporation serving the global ophthalmic surgical market, with products currently marketed in more than 60 countries. We design, manufacture and distribute a wide range of intraocular lens (IOL) implants and lens injection systems, and have an established reputation for rapid prototype design and development and high quality/low cost manufacturing.

In late April 2010, Lenstec received its first US FDA approval with the Softec HD
bi-aspheric lens. This lens is the first monofocal implant to be approved with 0.25D steps and is designed to be the most accurate IOL on the market today. It is a hydrophilic acrylic implant made from a hydrogel base material that is currently used by many other internationally known IOL companies worldwide.

In June 2010, Lenstec received its second US FDA approval with the Softec I implant. The Softec I is a traditional “non-aspheric” optic design with traditional 0.5D steps and in the same material and Mod-C loop design. It is a lens that provides a new technology material to the traditional IOL for a strong upgrade from low cost silicone implants for the cost-conscious ASC facility.

Founded in 1993, Lenstec currently has offices in Florida and the United Kingdom, and a 30,000 sq. ft. manufacturing facility in Barbados, designed by Lenstec to exceed all medical device standards.Company DescriptionAbout Lenstec \r
Lenstec, Inc. is a Florida-based medical device corporation serving the global ophthalmic surgical market, with products currently marketed in more than 60 countries. We design, manufacture and distribute a wide range of intraocular lens (IOL) implants and lens injection systems, and have an established reputation for rapid prototype design and development and high quality/low cost manufacturing.\r
\r
In late April 2010, Lenstec received its first US FDA approval with the Softec HD \r
bi-aspheric lens. This lens is the first monofocal implant to be approved with 0.25D steps and is designed to be the most accurate IOL on the market today. It is a hydrophilic acrylic implant made from a hydrogel base material that is currently used by many other internationally known IOL companies worldwide.\r
\r
In June 2010, Lenstec received its second US FDA approval with the Softec I implant. The Softec I is a traditional “non-aspheric” optic design with traditional 0.5D steps and in the same material and Mod-C loop design. It is a lens that provides a new technology material to the traditional IOL for a strong upgrade from low cost silicone implants for the cost-conscious ASC facility.\r
\r
Founded in 1993, Lenstec currently has offices in Florida and the United Kingdom, and a 30,000 sq. ft. manufacturing facility in Barbados, designed by Lenstec to exceed all medical device standards.

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