Opportunities

Please review our current opportunities to see if there’s a good fit for you. 

Here at Aquabiliti, we are a fast-growing, successful organization and have an opening for a Director of Quality Assurance for Class ll/lll Medical Devices and/or Injectable Pharmaceuticals.

Key responsibilities for this role will include:

  • Leading all QA/RA functions and related activities.
  • Maintenance and enhancement of the QMS in compliance with 21 CFR parts 820 & 210-211 and ISO 13485.
  • Being the lead role during regulatory (FDA and ISO) audits.
  • Enhancing product quality monitoring, identifying and prioritizing complaint trends, as well as leading the charge on a highly effective and robust CAPA system.
  • Participation in product life cycle development from concept to commercialization.
  • Implementation of strategies to achieve and enhance the individual growth of team members.

Key Requirements for this role include:

  • A Bachelor’s Degree in Engineering, Mathematics, or Science (Master’s Degree a plus).
  • At least 5 years minimum Quality Assurance and Regulatory Affairs related experience, with demonstrable success in a managerial role.
  • Class II/III Medical Device Experience.

We’ve experienced exceptionally strong growth, exceeding 30% plus each year, and are highly focused on innovation, which is just part of the reason why we’ve entered into a strategic partnership with Ropella, the world’s leading executive search and consulting firm.

Our company culture is warm, friendly, and very entrepreneurially driven. If you are an assertive leader, have experience in Research, Product Development, Testing, Validation and Manufacturing, and would like to be a key player in driving our company’s continued success, please connect with Timir Patel right away at 615 833 2633 or send him an email at careers@aquabiliti.com.

Maintain all plant equipment including production machinery and facilities equipment. Ensure a safe, clean work environment with a strong focus on quality and productivity.

EDUCATION REQUIRED:

Associate Degree in Electronics Engineering or Mechanical preferred, or equivalent experience with strong emphasis on Mechanical parts, PLC, pneumatics, hydraulics, and electrical/electricity.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Perform daily, weekly and monthly preventive maintenance on all plant equipment and document activities.
  • Perform trouble shooting, problem solving and countermeasure activities on all production and facility equipment.
  • Dismantle machines or equipment using hand tools or power tools to examine parts for defects and repair or replace and document activities.
  • Complete daily maintenance of status reports.
  • Work with and coordinate any contractor activity with appropriate documentation
  • Complete production start-up quality audits and documentation.
  • Provide training, guidance, and support to team members with machine operations

ADDITIONAL KNOWLEDGE, SKILLS AND ABILITIES:

  • Experience in programming and troubleshooting PLC and SLC ladder
  • Experience in operator interface programming such as panel views.
  • Familiarity with different motors/ servo controlled systems.
  • Ability to read and/or interpret engineering drawings (electrical, pneumatic, hydraulic, and mechanical)
  • Proficiency with computer aided drawing software, i.e. AutoCAD.
  • Ability to size electrical, pneumatic, and hydraulic circuits.
  • Strong verbal and written communication skills required.
  • Maintain strict confidentiality of any proprietary business-related information to which entrusted
  • Ability to work in a non-climate & controlled areas (where applicable)

Current Plant Equipment

  • Screw Compressors.
  • Horizontal Form, Fill & Seal Machine.
  • Accraply Label Applicator machine.
  • Sasib Flow Wrapper machine.
  • Centrifugal Bowls & Hoppers.
  • Shredder.
  • Rotary Filling Machine.
  • Laminar Hoods/HEPA filter clean rooms.

Our company culture is warm, friendly, and very entrepreneurially driven. Please connect with Dipen Patel right away at 615 833 2633 or send him an email at careers@aquabiliti.com.

Job Summary:

AQUABILITI is a medical device company that produces pre-filled IV flush syringes. Under the direction of the Production Supervisor, all Machine Operators will be responsible for manufacturing responsibilities on designated equipment, keeping to production schedules, and complying with all quality standards that apply to manufacturing and operations.

Essential Responsibilities/Functions:

To perform this job successfully, an individual must be able to perform each essential function satisfactorily:

  • Understand and follow manufacturing instructions and Quality System Requirements as per training
  • Read and understand engineering drawings, shop orders, work instructions and all operations and manufacturing instructions.
  • Meet and exceed production and quality goals
  • Perform daily duties in manufacturing areas such as completing daily labor sheets.
  • Work with the Director of Operations to resolve discrepancies and errors.
  • Follow up and correct problems if required.
  • Understand and comply with company safety rules and company policies.

Education and Experience:

High school diploma or equivalent with a minimum 3 years Machine Operations experience. Prior experience with ISO and FDA regulated medical device manufacturing preferred.

Skills and Abilities: The ideal candidate will possess the following qualifications:

  • Self motivated
  • Good hand and eye coordination
  • Flexibility with production schedule and ability and willingness to work overtime
  • Ability to lift 30 lbs.
  • Learns easily through on the job training
  • Willingness and ability to work on assignments that can be routine
  • Attention to detail
  • Maintain and promote an error free work environment with respect to documentation and record keeping
  • Good organizational skills
  • Ability to work cooperatively and effectively in a team environment
  • Manual Dexterity

 

Ready for a Challenge?

  • Are you an assertive, self-starter with a laser focus on winning?
  • Do you have the presence and persuasiveness to secure new business in a highly competitive market?
  • Do you have a problem-solving mind and the self-discipline to follow-through for your customers?

If so, as the National Sales Representative for Aquabiliti, you will be personally responsible to deliver new accounts and new markets across the country --- and you will be rewarded for the results you put on the board.   At Aquabiliti, we manufacture highest-quality, field-ready, sterile flush syringes for healthcare professionals across the United States.    We need an exceptional, travel-ready, high-performing sales professional to take our business to the next level.

We will expect you to possess uncompromising integrity, wicked-smart thinking and a tenacity to succeed.  In return, we will provide a big opportunity, real earning potential, and the support you need to drive top-line growth. 

If you think you can deliver, apply at careers@aquabiliti.com.

If this isn’t you, don’t waste your time, or ours.  This job isn’t for the faint of heart.