Quality Specialist - Alachua - RTI Surgical

    RTI Surgical
    RTI Surgical Alachua

    1 day ago

    Description

    Quality Assurance Specialist

    Location: Alachua, FL

    Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.

    Responsibilities:

    • Supports quality system compliance with the appropriate internal and external regulatory requirements and maintains awareness of the overall regulatory landscape
    • Collects, analyzes, and reports data elements to demonstrate conformity and maintains the effectiveness of the quality management system with a high degree of accuracy
    • Contributes to the company process improvement initiatives that impact quality systems and works collaboratively with cross-functional stakeholders to ensure compliance of processes and procedures within the quality management system
    • Supports audit and inspection preparation, resolution of audit and inspection findings, and coordinates with auditing groups and inspectors through all stages of the audits
    • Applies for and maintains the company's quality management system licensure including registration and recertification to ensure all licenses stay current
    • Acts as a subject matter expert during internal and third-party audits for responsible processes
    • Supports all elements of audit planning, execution, closeout, and follow-up with a high level of customer service
    • Other duties as assigned

    Requirements:

    Education:

    • Bachelor's Degree

    Experience:

    • 0-3 years of experience in quality assurance, systems, regulatory affairs, or other relevant experience within a regulated industry such as tissue, medical device, or pharmaceutical
    • Additional experience may substitute for education requirement

    Certification:

    • Lead Auditor Certification

    Skills:

    • Excellent verbal and written communication
    • Microsoft Office Suite
    • Quality Management System (QMS) software
    • Presentation
    • Auditing

    Travel:

    • N/A

    Safety:

    Physical Requirement:

    • Move or lift objects up to 25 pounds
    • Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
    • Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

    Working Environment:

    • Onsite: Office environment with assigned workstation
    • Remote positions only: Home office environment with minimum distractions

    More about Evergen:

    Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

    Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

    • Accountable: We own our actions and decisions.
    • Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
    • Growth Mindset: We embrace challenges as opportunities for continuous learning.
    • Customer-Centric: We prioritize customers at every touch point.
    • Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.

    At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

    Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.

  • Work in company

    Quality Specialist

    Only for registered members

    The Quality Specialist supports quality system compliance with internal and external regulatory requirements at Evergen. · ...

    Alachua, FL, US

    1 week ago

  • Work in company

    Quality Assurance Specialist

    Only for registered members

    We are looking for a self-starting individual with a high level of personal accountability to support our mission to provide safe, high quality, · human tissue for transplantation.Review quality assurance records such as cleaning logs, · supply logs, equipment files and temperatu ...

    Alachua, FL

    6 days ago

  • Work in company

    Quality Specialist

    Only for registered members

    This is a Quality Specialist role at Evergen. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL. · ...

    Alachua

    1 week ago

  • Work in company

    Quality Specialist

    Only for registered members

    We are seeking a Quality Specialist to support our quality system compliance with internal and external regulatory requirements. The successful candidate will collect, analyze and report data elements to demonstrate conformity and maintain the effectiveness of our quality managem ...

    Alachua Full time

    1 week ago

  • Work in company

    Quality Assurance Specialist

    Only for registered members

    We are looking for a self-starting individual with a high level of personal accountability to support our mission to provide safe, high quality, human tissue for transplantation.To be successful as a quality assurance specialist you must be thorough, detail oriented and successfu ...

    Alachua

    6 days ago

  • Work in company

    Quality Assurance Specialist

    Only for registered members

    We are looking for a self-starting individual with a high level of personal accountability to support our mission to provide safe, high quality, · human tissue for transplantation. · ...

    Alachua, FL

    6 days ago

  • Work in company

    ECMO Specialist | Full TIme | 3/12s | ECMO | Gainesville

    Only for registered members

    The ECMO Specialist is responsible for daily operation of the ECMO program under direction of the ECMO Coordinator. · Maintain effective assessment of ECMO circuit function and integrity. · Ensure administration of blood products accurate and safe for patients ranging neonatal to ...

    Gainesville Full time

    1 week ago

  • Work in company

    ECMO Specialist

    Only for registered members

    We are seeking an experienced ECMO Specialist to join our high-acuity Critical Care team. · Manage ECMO circuits and related equipment. · Maintain circuit integrity and ensure patient safety. · Support hemodynamic stability and perfusion within ordered parameters. · ...

    Gainesville

    5 days ago

  • Work in company

    Sales Manager

    Only for registered members

    The Sales Manager is an individual who is highly sociable, · draws energy from working with people, · and is optimistic and outgoing. · Hiring Buyer Specialists and Showing AssistantsTraining Buyer Specialists and Showing AssistantsHolding accountable all Buyer Specialists and Sh ...

    Gainesville

    4 days ago

  • Work in company

    Internal Medicine Physician

    Only for registered members

    We are seeking a dedicated Internal Medicine Physician to join our team in Gainesville, · Gainesville community. · ...

    Gainesville

    1 month ago

  • Work in company

    Internal Medicine Physician

    Only for registered members

    Seeking · a dedicated Internal Medicine Physician in Gainesville, · FL to provide comprehensive primary care services. ...

    Gainesville

    1 month ago

  • Work in company

    Clinical Pharmacist BMT

    Only for registered members

    The Transplant Cellular Therapy Clinical Pharmacy Specialist provides comprehensive clinical pharmacy services for the TCT clinic. · Candidates MUST HAVE TCT, CAR-T, or BMT EXPERIENCE. · ...

    Gainesville

    1 month ago

  • Work in company

    Physician - Internal Medicine

    Only for registered members

    We are seeking a dedicated Physician specializing in Internal Medicine to join our team in Gainesville Florida. · Provide comprehensive primary care to adult patients including diagnosis treatment and prevention of illnesses. · Manage chronic conditions and coordinate patient car ...

    Gainesville

    1 month ago

  • Work in company

    ECMO Specialist | Full TIme | 3/12s | ECMO | Gainesville

    Only for registered members

    The ECMO Specialist is responsible for the daily operation of the ECMO program under the direction of the ECMO Coordinator. They are expected to maintain and effectively assess ECMO circuit function and integrity. · Maintain and effectively assess ECMO circuit function and integr ...

    Gainesville, FL Full time

    1 week ago

  • Work in company

    Human Resource Specialist

    Only for registered members

    The Human Resource Specialist is responsible for providing support to operations for various human resources responsibilities including training, recruitment, hiring, onboarding, HR compliance and retention. · The HR Specialist should partner with each service site to develop and ...

    Gainesville

    1 month ago

  • Work in company

    Human Resource Specialist

    Only for registered members

    The HR Specialist is responsible for providing support to operations for various human resources responsibilities including training, recruitment, hiring, onboarding, HR compliance and retention. · Providing administrative support in the areas of employee recruitment, hiring, ret ...

    Gainesville

    1 month ago

  • Work in company

    Carside / Take Out Specialist

    Only for registered members

    We are looking for Carside / Take Out Specialists who will serve each to-go guest courteously, · quickly and efficiently with a sincere, positive, pleasant and enthusiastic attitude. · Get paid DAILY We've partnered with Rain to offer you the ability to get 50% of your pay within ...

    Gainesville

    1 month ago

  • Work in company

    Carside / Take Out Specialist

    Only for registered members

    We're looking for Full Time & Part Time: Carside / Take Out / To Go Specialists You will be responsible for serving each to-go guest courteously, quickly and efficiently with a sincere, positive, pleasant and enthusiastic attitude. · ...

    Gainesville

    3 weeks ago

  • Work in company

    Physician Internal Medicine

    Only for registered members

    We are seeking a dedicated Physician specializing in Internal Medicine to join our team in Gainesville.We are looking for someone with strong clinical skills and excellent communication to provide comprehensive primary care services. · Provide routine check-ups and health screeni ...

    Gainesville

    1 month ago

  • Work in company

    OPEX Specialist

    Only for registered members

    +We are seeking an experienced OPEX Specialist in Gainesville. This position will lead transformative initiatives enhancing efficiency across the organization. · ++Bachelor's degree in engineering or equivalent combination of education and experience · Minimum 5 years of experie ...

    Gainesville

    1 week ago

  • Work in company

    Plasma Center Paramedic – EMT-P

    Only for registered members

    As a Medical Support Specialist at BioLife Plasma Services, you will determine donor eligibility and manage medical emergencies. · Determine donor eligibility to donate plasma. · Manage donor adverse events and review laboratory test results. · ...

    Gainesville $23.85 - $32.79 (USD)

    1 month ago

Jobs
>
Quality specialist
>
Jobs for Quality specialist in Gainesville