Quality Engineer – Medical Device


Quality Engineer – Medical Device

Cincinnati, OH

Organization: CSafe

Salary: based on experience


  • Are you ready to utilize your quality engineering experience to join a fast-growing, very successful and reputable organization with opportunities for career advancement?
  • Do you enjoy collaborating on complex quality operation processes?



Our long-time client, CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive the medicines and treatments they need.

With a “patient-centered” focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products in both the active and passive segments. CSafe is the only provider with an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases allowing our team to match your requirements to the best solution for your needs. Any size, any duration and any temperature – CSafe is at the heart of your cold chain.


To ensure the success of CSafe Air Cargo Quality Management Systems by assisting in the planning, development, implementation, communication, and maintenance of such systems and documents which support regulatory and internal requirements. The Quality Engineer will be responsible for:

  • The design, establishment, implementation, and maintenance of CSafe Air Cargo quality manuals, procedures, work instructions, systems, processes, etc. related to the quality management system. The quality management system will be based on the needs of the company based on compliance with FAA 14 CFR Parts 21, 65, and 145 regulations as well as ISO9001, ISO13485, FDA QSR, etc.
  • Organization of audit schedules and the performance of customer, supplier, and/or internal audits as applicable.
  • Coordination of and support with improvement projects through data collection and analysis and determination of corrective and preventative action



  • Knowledge of Quality Management systems, basic quality-related statistics, and skilled in the application of the fundamentals of Quality Assurance and Quality Control.
  • Minimum 5 years of experience in Quality Management system documentation, auditing, and implementation.
  • Excellent understanding of continuous improvement concepts and processes including Six Sigma and Lean.
  • FAA 14 CFR Part 21 and/or 145 experience a plus.
  • Associate or higher education in the field of Engineering or Quality Technology preferred. Progressively more responsible experience in the field of quality may be substituted for formal education.
  • ASQ or RAB Certified Auditor or other quality auditor training and experience a plus
  • Supplier control and performance of on-site supplier audits experience a plus
  • Proficiency in MS Office (Word, Excel, Powerpoint) a must, Sharepoint experience a plus
  • Willing to travel up to 20%.



  • Strong interpersonal skills and ability to work with others in a team environment.
  • Ability to work effectively in a fast-paced, dynamic environment.
  • Strong attention to detail and accuracy.



This is an outstanding opportunity to work for a very successful, growing organization that is extremely reputable in the industry. This role will allow the right person to learn the organization and grow your career with the organization.



Gilman Partners is committed to strengthening leadership teams and elevating the talent in our communities. CSafe Global is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.You don’t have to meet every qualification in this job description to apply. If you’re drawn to the position and believe your experience makes you a good fit, we encourage you to reach out.



CSafe has outstanding benefits including Paid Time OFF (PTO) starting at 25 days & Paid Holidays, Medical, Dental and Vision Insurance, 401k with 100% Employer Match, Group Life & Disability, Health Spending Account Options, Tuition Reimbursement, Employee Assistance Program, Travel Assistance Program, Financial Wellness Program, Paid Parental Leave, Referral Bonus Program, Gym Membership Reimbursement.