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ATS Company:  Comecer
Requisition ID:  4959

Indianapolis, IN, US, 46250 Chicago, IL, US, 60008-3833

Date:  May 19, 2023

Quality Engineer

Job Description


Comecer, an ATS company, develops and manufactures high-tech systems for Aseptic Processing and Containment in Pharmaceutical and Nuclear Medicine Industries, specializing in isolation technology solutions for regenerative medicine and tissue engineering. 


Essential Job Duties

  • Support colleagues in drafting and finalizing technical documents and the interpretation and application of legal, regulatory and project requirements
  • Quality management of orders in relation to:
    • Specific validation (DQ)
    • Validation documentation
    • Process controls
  • Develop inspection methods to analyze product quality
  • Implement a working system to ensure conformity and accuracy in the production process
  • Ensure products compliance with company and international quality standards
  • Ensure that the product corresponds to the desired technical specifications and take corrective action to resolve non-conformities
  • Plan and document control activities and inspections
  • Other duties as required.



  • Bachelor’s degree or post-secondary education in Quality Control, Engineering, Nuclear Medicine, or Microbiology.
  • Technical or engineering experience required, aseptic processing and containment strongly preferred
  • Previous experience in similar role required
  • Knowledge of quality management systems and procedures
  • Knowledge of methods to apply to resolve non-conformities
  • Knowledge of regulations applicable to Comecer products and certification processes.
  • Ability to work effectively with internal, cross-functional teams and customers according to deadlines and under pressure-filled conditions.
  • Self-driven, attentive to detail, consistent, and process driven.
  • Fluent in English, written and oral, fluent in Italian is an asset
  • Excellent time-management skills and ability to efficiently coordinate multiple projects at a time.
  • Proficient with Microsoft software tools including Outlook, Project, Word, Excel, and Power Point
  • Must be eligible and able to travel domestically & internationally within 30 days from hire date and legally eligible to operate a vehicle, as this is an essential job function.

Benefits ATS Comecer USA offers:

  • Medical, Dental, and Vision Insurance
  • 401k matching
  • 10 Paid Holidays
  • Paid Vacation


To keep our employees safe:

  • While Traveling for work
    • Travel Preparedness Kits (KN95 masks, hand sanitizer, sanitizing wipes, and disposable gloves)
  • Onsite
    • Hand sanitizer dispensers placed throughout the facility
    • Require social distancing
    • Provide disposable gloves and respirators upon request
    • Conduct visitor health assessments


*Visa sponsorship is not available for this role

Nearest Major Market: Indianapolis

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