Quality Engineer

ATS Automation Tooling Systems Inc; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Comecer in Indianapolis, IN seeks a Quality Engineer to support project managers in quality management across the full lifecycle of radiopharma, pharma and ATMP projects in North America. The role includes design reviews, FAT, SAT, IQ, OQ and PQ activities related to VPHP cycle development.

The position requires coordinating with the technical team and third parties at customer sites to perform validation activities and maintain QA controls to meet regulatory requirements.

Qualifications

• Ability to communicate efficiently and effectively with people at all levels of the organization, both verbally and in written form.
• Strong problem-solving ability.
• Hands-on and able to meet deadlines.

Responsibilities

• 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) and process controls.
• Work with technical team and third parties at customer sites to perform SAT, IQ, OQ, VPHP Cycle development and VPHP PQ activities.
• Develop and maintain quality procedures and controls at Comecer Inc. facilities in North America to conform to customer and regulatory requirements.
• Establish regulatory approval for Comecer disposable kits for sale in North America.
• Develop inspection methods to analyze product quality.
• Implement a working system to ensure conformity and accuracy in the production process.
• Ensure products comply with company and international quality standards.
• Ensure that the product conforms to the desired technical specifications and take corrective action for non-conformities.
• Plan and document control activities and inspections.
• Other duties as required.

Skills

Communication

Problem solving

Hands-on

Education

Bachelor’s degree in technical field

Tools

ISO 9001

Microsoft Office

Job description

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Requisition ID: 17601

Location: Indianapolis, IN, US, 46250

Date: Aug 7, 2026

Quality Engineer

Job Description

The Quality Engineer supportsComecerProject Managers in the management of the orders from a quality point of view throughout the project including design reviews, FAT, SAT, IQ, OQ and some aspects of PQ as they relate to VPHP cycle development.

The markets this position services include Radiopharma, Pharma and Cell & Gene Therapy (ATMP) projects in North America; including, but are not limited to:

Radiopharma – shielded hot cells and automation, synthesis and dispensing modules for vials and syringes, LAF shielded isolators, sterility testing isolators, VPHP generators for sterilization, solid target processing systems, dose calibrators, glove testers, and VPHP sterilization modules

Pharma –aseptic handling and filling of liquid and powder APIs, dispensing custom R&D isolators, potent API processing Isolators (PAPI), modular sterility testing isolators (MSTI), ATEX isolators, Baby Phill small batch vial filling, Combo Phill aseptic filling line for RTU vials syringes, cartridges, fully automated combination product end-to-end filling systems, Speedy Glove,DeconBox™

Cell & Gene Therapy (ATMP) – modular cell culture isolator (MCCI), incubation system for advanced therapy labsFlexyCult™

Additional Information

ESSENTIAL JOBDUTIES:

Quality

• Supportcolleaguesin draftingandfinalizingtechnical documents and the interpretation and application of legal, regulatory and project requirements


• Quality management of orders in relation to:


• Specific validation (DQ)


• Process controls


• Work with technical team in the field as well as 3rdparties at customer sites to perform and successfully complete SAT, IQ, OQ, VPHP Cycle development and VPHP PQ activities.


• Work with other colleagues to develop andmaintainquality procedures and controls atComecerInc. facilities in North America to conform to customer and regulatory requirements.


• Work withComecerquality personnel and 3rdparties to establishregulatory approval forComecerdisposable kits for sale in North America


• 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 asrequired.

Qualifications

QUALIFICATIONS:

• Bachelor’s degree in technical field or equivalent experience.


• Quality Engineering experience in a manufacturing environmentpreferred.


• Experience withInternational Standardization Organization(ISO) standards9001preferred.


• Ability to communicate efficiently and effectively with people at all levels of the organization, both verbally and in written form.


• Strong problem-solving ability.


• Proficient inMicrosoft Office suite.


• Must be hands-on and must be able to meet deadlines for his or her responsibilities either directly or indirectly.

JOB SPECIFICATIONS:

• The employee may be required to stand, walk, push, pull, reach overhead, and bend to the floor.


• Exert up to 50 pounds of force occasionally, and/or exert up to 10 pounds of force frequently.


• Visualacuity – Normal requirements for reading written instructions and computer screens.


• Hearingability – Normal requirements for understanding verbal instructions.


• Workingconditions – The employee is subject to a normal office environment with occasional exposure to high noise levels and/or physical hazards when visitingthe manufacturingfloor.


• Capable of wearing appropriate related PPE for extended periods of time.