Career Opportunity
MedOne Surgical, Inc. is a fast-growing, family-owned small business located in Sarasota, Florida, USA. As the MedOne name gains notoriety, we are continually seeking additional members for our product specialist team.
Do you think you have what it takes to be a part of the MedOne family? Apply today!
MedOne Surgical, Inc.
670 Tallevast Road
Sarasota, FL 34243
T: 941.359.3129
[email protected]
Currently Hiring For:
Quality Manager
Job Description:
Manage various QMS operations to ensure compliance with written procedures and established processes. Manage inspection activities for components, in-process and finished products. Oversee calibration and preventative maintenance activities. Work with engineering to resolve manufacturing process quality problems including evaluation of components, suppliers and manufacturing process. Conduct complaint and CAPA investigations. Interface with regulatory authorities including FDA and notified bodies to maintain compliance with all required regulations.
Job Requirements:
– The preferred candidate must meet the following requirements;
– Two or four year technical degree in Mechanical or Industrial Engineering or similar field.
– Experience in process validation, statistical sampling techniques, root cause analysis and related processes.
– Familiarity with FDA Quality System Regulation (GMP), ISO 13485 and related quality standards.
– Previous medical device QMS experience, preferably with sterile devices.
– Excellent verbal and written communication skills in English.
– Regular and predictable attendance
– While performing the duties of this job, the employee is regularly required to sit, stand, walk and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, peripheral vision, depth perception and ability to adjust focus. The employee must occasionally lift and/or move up to 50 pounds.
Salary based on qualifications and experience
Drug free/Tobacco free workplace
Full-Time, in-office position
Health, Medical, Dental & Vision benefits
Paid PTO, Paid Holidays
401(k)
Quality Technician
Job Description:
Follow established procedures for the inspection, testing and acceptance of components and assemblies used in the manufacture of medical devices. Perform review of Device History Records and other documentation for release of finished goods. Asses nonconforming materials and determine appropriate disposition. Assist in writing, reviewing and updating Quality documents. Maintain vendor files to ensure they are approved and in compliance. Monitor critical equipment and instrumentation to ensure proper operation and calibration. Assist with R&D projects. Other work related duties to fulfill hours scheduled.
Job Requirements:
– High School Diploma or equivalent
– Excellent verbal and written communication skills in English.
– Good arithmetic skills
– Mechanical aptitude required
– 2+ years QC experience in Receiving Inspection is preferred
– Working knowledge of measurement instruments
– Microsoft Office software experience required
– Regular and predictable attendance
– While performing the duties of this job, the employee is regularly required to sit, stand, walk and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, peripheral vision, depth perception and ability to adjust focus. The employee must occasionally lift and/or move up to 50 pounds.
Pay based on qualifications and experience
Drug free/Tobacco free workplace
Full-Time, in-office position
Health, Medical, Dental & Vision benefits
Paid PTO, Paid Holidays
401(k)
Medical Device Assembly
Job Description:
- Work in cleanroom environment assembling detailed medical devices while sitting
- Hand-eye coordination and good visual acuity required
- Must be able to understand and communicate in English
- Drug free / Tobacco free workplace
- High School Diploma or equivalent
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid holidays and PTO
- Vision insurance
Schedule:
- Monday – Friday, 7:00am – 3:30pm
Customer Service Representative
Job Description:
Responsible for all activities associated with customer service including: order taking, order fulfillment, invoicing, returns, samples, estimates, payment process, collections and maintenance of customer records. Manage customer data in QuickBooks to ensure all information is accurate and updated. Also responsible for front door reception, managing MedOne e-mail account, incoming phone call first contact, maintain stock of finished goods inventory and other work related duties to fulfill hours scheduled.
Job Requirements:
- The preferred candidate must meet the following requirements:
- High school diploma or equivalent
- Computer proficient with experience in Office software including Word, Excel, and QuickBooks software
- Courteous and professional telephone skills
- Organized, adaptable, accurate, flexible
- Able to sit at desk for extended period of time
- Able to pack, lift, and move shipping boxes up to 25 lbs
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
- Paid Holidays and PTO
Schedule:
- Monday – Friday, 8:30am – 5:00pm
Project Engineer
Job Description: Project Engineer supports engineering functions at a Medical Device manufacturing facility through a variety of
tasks including:
- Project management
- Research materials & develop specifications
- Assist with product development and prototyping
- Testing and data analysis
- Implement new processes, process improvements or equipment
- Technical writing including operational procedures and technical reports
- Create items using CNC and 3D print technology
- Evaluate product failures &; propose corrective actions
- Assist with automation development / fabrication
- Perform equipment / process validation
- Ensure compliance with established QMS procedures and processes
Job Requirements: The preferred candidate must meet the following requirements:
- Minimum two year technical degree or technical certificate
- Detail oriented with good organizational skills
- Proficient in Solidworks required
- Able to handle multiple projects simultaneously
- Proficient in technical writing
- Familiar with statistical techniques
- Understanding of ISO 13485 / FDA requirements preferred
- Medical device experience preferred
- Excellent verbal & written communication skills
- Proficient with MS Office Suite programs, including Word and Excel
- Regular and predictable attendance
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. Specific vision abilities required by this job include; close vision, peripheral vision, depth perception and ability to adjust focus. The employee must occasionally lift and/or move up to 50 pounds.
- Related tasks and other work related duties as assigned
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid holidays and PTO
- Vision insurance
- 8 hour shift
- Monday – Friday
- Updated on:
- 23 October 2024
