Documentation Specialist

4 weeks ago


Indianapolis, United States Intersurgical, Inc. USA Full time

About Us

Intersurgical Inc. is a global leader in medical device manufacturing. We partner with providers, manufacturers and other organizations to supply innovative airway and medical devices that impact the lives of patients every day.

Driven by our commitment to supply high quality medical devices, our team works to deliver best in class products to over 60 countries worldwide.

Our Culture

At Intersurgical Inc. we celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic selves.

We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view you'll bring to the table while fostering a spirit of communication.

Purpose

As the Labeling & Documentation Specialist you will play a critical role in ensuring that our labels fufill company style and regulatory requirements. You’ll have the opportunity to learn from the individuals that have played a part in building the business while helping thousands of people worldwide.

Responsibilities:

  • Assist with ensuring labeling and directions for use comply with all applicable regulatory requirements
  • Control labeling and Directions for Use accessible for production use
  • Assist with preparing and maintaining labels and directions for use as directed
  • Prepare and maintain labeling/IFU (Instructions for Use) charges as directed by Regulatory affairs department
  • Coordinate and submit Engineering Change Notices upon request
  • Distribution/notification activities after Engineering Change Notice approval if applicable
  • Maintain Device Master Record (DMR) files
  • Assist in maintaining company documentation and records
  • Coordinate notifications of documentation required training as needed

What We’re Looking for

  • 0-3 years experience in labeling and translations within the medical device industry
  • Must be able to speak, read, and write English
  • Competency in Microsoft Word, Adobe Acrobat and Excel

It Would Be Great If You Have

  • In-depth understanding and experience with US FDA, CE and ISO Regulatory requirements
  • Bachelor's degree in quality, risk management or related field
  • SolidWorks Experience
  • Adobe Indesign Experience

Requirements

  • Must be able to sit, stand and/or walk for extended periods of time
  • Temperature controlled facility with office and light manufacturing environment; non-smoking; safety hazards minimal; company provided smock and hairnet mandatory in all controlled production areas.

Intersurgical is an Equal Opportunity Employer that takes pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.

Benefits

We are passionate about the well-being of others and that begins with caring for our people.

  • 💰 Competitive salary
  • 🧠 Multiple opportunities to be challenged and step up your career in a fast-growth company
  • 📈 401k match & profit sharing
  • 🏖️ Paid Vacation and holidays
  • 😌 Medical, dental, and vision benefits
  • 👀 Much more...


  • Indianapolis, United States RayzeBio Full time

    Job Title: Document Control SpecialistLocation: IndianapolisNH: 39BackgroundRayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted...


  • Indianapolis, United States RayzeBio Full time

    Job Title: Document Control SpecialistLocation: IndianapolisNH: 39BackgroundRayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted...


  • Indianapolis, United States RayzeBio Full time

    Job Title: Document Control SpecialistLocation: IndianapolisNH: 39BackgroundRayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted...


  • Indianapolis, United States Creative Financial Staffing Full time

    Procurement Specialist ABOUT THE COMPANY: Our client is seeking a dynamic and experienced Procurement Specialist to join their team. You will play a crucial role in ensuring the smooth functioning of our airport operations by managing procurement processes efficiently and effectively. You will be responsible for sourcing, negotiating, and purchasing goods...


  • Indianapolis, United States Masterapp Labs Full time

    Job Description:Onsite.Phone and in-person interview.This position requires a high level of professionalism and objectivity to ensure that only qualified enterprises gain access to program resources. Do you accept this requirement?This is a position of trust and requires the ability to maintain a high level of confidentiality due to the types of personal and...


  • Indianapolis, United States Masterapp Labs Full time

    Job Description: Onsite. Phone and in-person interview. This position requires a high level of professionalism and objectivity to ensure that only qualified enterprises gain access to program resources. Do you accept this requirement? This is a position of trust and requires the ability to maintain a high level of confidentiality due to the types of personal...


  • Indianapolis, United States SilverXis, Inc. Full time

    Job DescriptionJob DescriptionJob Title : Admin Assistant /Certification SpecialistLocation : Indianapolis INPay rate : $20 per hour W2 (Onsite)Estimated Work Duration : 06/03/2024 to 12/31/2024Phone and in-person InterviewThe MBE/WBE Certification Specialist supports the Division of Supplier Diversity's mission of providing equal opportunity in State...

  • Product Specialist

    4 weeks ago


    Indianapolis, United States Schneider Geospatial Full time

    Description The Schneider Geospatial Product Specialist will setup new clients with Schneider Geospatial's online permit tracking, work order, and asset management SaaS products, working closely with client contacts to ensure a smooth implementation. Setup activities are followed by client training, workflow documentation, and software configuration to...


  • Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full time

    Job Description Employee Responsibilities: Complete data integrity review of analytical data reporting records for the client’s portfolio, which includes Synthetic molecules, Peptides, and Bioproducts Support development stability studies which include handling, storing, delivering samples, and documenting per relevant procedures Assist domestic and...

  • Quality Specialist

    2 weeks ago


    Indianapolis, United States Pivot Workforce, LLC Full time

    Quality Specialist What you will be doing: The Quality Specialist will be responsible for overseeing and implementing quality assurance processes to ensure the products and services meet company standards and customer expectations. They will collaborate with various departments to identify areas for improvement, develop quality metrics, audit current...

  • Quality Specialist

    2 weeks ago


    Indianapolis, United States Pivot Workforce, LLC Full time

    Quality Specialist What you will be doing: The Quality Specialist will be responsible for overseeing and implementing quality assurance processes to ensure the products and services meet company standards and customer expectations. They will collaborate with various departments to identify areas for improvement, develop quality metrics, audit current...

  • Quality Specialist

    2 weeks ago


    Indianapolis, United States Pivot Workforce, LLC Full time

    Quality Specialist What you will be doing: The Quality Specialist will be responsible for overseeing and implementing quality assurance processes to ensure the products and services meet company standards and customer expectations. They will collaborate with various departments to identify areas for improvement, develop quality metrics, audit current...


  • Indianapolis, United States ATC Inc Full time

    Essential Duties/Responsibilities:• Audits all certification applications, both new and re-certifications, to determine program eligibility, reviews requests for certification based on agreements with other certifying bodies, and reviews classification code amendment requests;• Analyses the application form and the accompanying documentation supplied by...

  • it specialist

    3 weeks ago


    Indianapolis, Indiana, United States Department Of Defense Full time

    SummaryWho may apply: This announcement is open to all U.S. Citizens Position located in: Info & Tech Dir., Payroll Services, DJMS-AC Software Engineering -ZTBBB Applicants on Cleveland list may be considered for positions in Bratenahl. OPM Pay tables: Pay for first time hires to the Federal Government will typically be set at step 1 salary range for their...


  • Indianapolis, United States enableIT Full time

    Onsite- INDIANAPOLISThe Technology Support Specialist performs daily routine technical support. This professional consults with the supervisor for task prioritization and effectively applies technical knowledge. This individual also specializes in one or more areas, including support center/technology support, networking, telecommunications, help desk, and...


  • Indianapolis, United States enableIT Full time

    Onsite- INDIANAPOLISThe Technology Support Specialist performs daily routine technical support. This professional consults with the supervisor for task prioritization and effectively applies technical knowledge. This individual also specializes in one or more areas, including support center/technology support, networking, telecommunications, help desk, and...


  • Indianapolis, United States enableIT Full time

    Onsite- INDIANAPOLISThe Technology Support Specialist performs daily routine technical support. This professional consults with the supervisor for task prioritization and effectively applies technical knowledge. This individual also specializes in one or more areas, including support center/technology support, networking, telecommunications, help desk, and...


  • Indianapolis, United States ATC Full time

    Essential Duties/Responsibilities:• Audits all certification applications, both new and re-certifications, to determine program eligibility, reviews requests for certification based on agreements with other certifying bodies, and reviews classification code amendment requests;• Analyses the application form and the accompanying documentation supplied by...


  • Indianapolis, United States ATC Full time

    Essential Duties/Responsibilities:• Audits all certification applications, both new and re-certifications, to determine program eligibility, reviews requests for certification based on agreements with other certifying bodies, and reviews classification code amendment requests;• Analyses the application form and the accompanying documentation supplied by...


  • Indianapolis, United States ATC Full time

    Essential Duties/Responsibilities:• Audits all certification applications, both new and re-certifications, to determine program eligibility, reviews requests for certification based on agreements with other certifying bodies, and reviews classification code amendment requests;• Analyses the application form and the accompanying documentation supplied by...