Quality Engineer
Job Location:
Indianapolis, IN - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
TheQuality EngineersupportsComecerProject 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 includeRadiopharma 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 GloveDeconBox
Cell & Gene Therapy (ATMP) modular cell culture isolator (MCCI) incubation system for advanced therapy labsFlexyCult
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)
- Validation documentation
- 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 toestablishregulatory 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:
- Bachelors 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.
Required Experience:
IC
About Company
As a global automation and technology leader, ATS Corporation supports some of the world’s most successful companies in bringing products to market.
