Position: Quality Management / Regulatory Affairs Co-Op
ACE Medical Company specializes in the manufacture and distribution of niche surgical instruments and equipment. Founded in 2012 and based in Cincinnati, Ohio, we work closely with several of the world’s foremost manufacturing facilities. Together our innovative and dynamic team is disrupting outdated instrument systems and processes to provide overall customer value that transforms a surgeon’s abilities to deliver medicine more efficiently than ever before. Join our team, and you will help evolve the medical world!
ACE Medical and the Ebner Medical family of companies are recruiting for a Quality Engineering Co-op/ Intern. ACE Medical offers a broad range of products, platforms, and technologies—including rongeurs, scissors, bipolars, leksells, dilators, bougies, microscissors, devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of neuro and spine conditions. Specialties services are, but not limited to: Neurosurgery, Spine Surgery, ENT, Plastic Surgery, Urology, General and Orthopedic surgeries.
As a Co-op/ Intern in Quality Engineering / Regulatory Affairs, you will have the chance to:
● Work withing an ISO 13485 Certified and 21 CFR 820 approved quality management system.
● Lead Efforts for our 2023 Management Review.
● Work directly with the CEO and Logistics Manager to exceed expectations for Traceability.
● Manage incoming shipments including documentation for incoming inspections.
● Regulatory Assistance including but not limited to: Predicate Device Reports, preparation, and submission of regulatory documents.
● Project Management ensuring testing validations are completed and timelines for production are met.
● Meet with Upper management to discuss risks and opportunities for the respective projects.
● Work with a Laser to apply 2D Data matrix and related projects, logos, rotary, etc.
The Quality Engineering Co-op/ Intern shall:
● Work onsite at our Cincinnati (Walnut Hills) Office
● Perform in Quality Systems and be actively involved in New Product Development/R&D
● Report directly to, and receive assignments from, the team manager, while also working with the sales and marketing departments for additional experience
● 40 hours per week required, may be more depending on work
2230 Park Avenue, Suite #202 * Cincinnati, Ohio 45206 * www.acemedicalco.com (P) (800) 822-0314 * (F) (513) 321-0055 * info@acemedicalco.com
Qualifications:
● Actively enrolled in an accredited College/University pursuing a bachelor’s or master’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Electrical Engineering, Computer/Software Engineering, Industrial Engineering or a related field
● Class standing of a Sophomore or above at the start of the Co-Op term
● GPA of 3.3 or above
● Availability to work Full-time, 40 hours per week
● Legally authorized to work in the United States and not require sponsorship for employment visa status (e.g., H1-B status) now or in the future
● Detail-oriented, highly organized and able to manage multiple tasks with minimal guidance
● Ability to work independently, as well as, on a team
● Proficiency with Microsoft Office (Word, Excel, Power Point) and have strong oral and written communication skills
● Must be familiar with basic statistics concepts/terminology
● If not in an engineering application- other roles are acceptable (i.e., budget management from a club, or any experience working with numbers)
Preferred:
● Demonstrated leadership/participation in campus programs and/or community service activities
● Previous quality engineering related experiences
● Knowledge of FDA or regulatory guidance
● Medical related experience (previous co-op at medical device company, working volunteering at a hospital, etc.)
● Advanced familiarity with statistics concepts/terminology (either from previous co-ops or classwork)
● Understanding of risk management Failure analysis/root cause understanding
Interested? Please visit our online form, fill out the Quality Management / Regulatory Affairs application, we will be in touch with all qualified candidates.