- Actalent (Irvine, CA)
- …Quality Engineer Job Description We are seeking a diligent and detail-oriented Quality Engineer with expertise in Trackwise to ensure compliance with ... NCR, CAPA processes, and regulatory requirements for medical devices. + ASQ Certified Quality Engineer (CQE) or equivalent preferred. Work Environment You will… more
- Medtronic (Billerica, MA)
- …for this opening will close on - 11 Jun 2025 Position Description: Principal Quality Engineer for Medtronic, Inc located in Billerica, MA. Develop, modify, apply ... Gage R&R. Coordinates Corrective & Preventive Actions (CAPA) using TrackWise or similar QMS software tools, Nonconformance, Change Control,...field. Requires five (5) years of experience as a Quality Engineer , Manufacturing Engineer , or… more
- Stryker (San Jose, CA)
- **Stryker** is hiring a **Staff Software Quality Engineer , Post Market** to support our Medical's Digital Health division and portfolio Software as a Medical ... Device (SaMD)/Software in a Medical Device (SiMD) to support projects as a quality engineer for post-market activities to drive customer quality . **Workplace… more
- United Therapeutics (Research Triangle Park, NC)
- …with suppliers and contract manufacturing organizations **Additional responsibilities of the Quality Engineer II:** + Present technical information on projects ... to product quality **Minimum Requirements of the Quality Engineer I:** + Bachelor's Degree in...System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise and Empower software systems + Previous experience with… more
- Integra LifeSciences (Boston, MA)
- …pathways to advance patient outcomes and set new standards of care. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is responsible for ... work with minimal guidance and direction. + The Senior Quality Engineer I works to achieve operational...audits (ie, Notified Bodies and FDA). + Knowledge of TrackWise preferred. + Knowledge of Agile product lifecycle management… more
- Medtronic (Menlo Park, CA)
- …window for this opening will close on - 11 Jul 2025 Position Description: Sr. Quality Engineer for Medtronic, Inc. located in Menlo Park, CA. Responsible for ... Complaints and validation activities using QAD, SAP, Agile and Trackwise while providing expert Quality Assurance (QA)...discipline and two (2) years of experience as a Quality Engineer or related occupation in medical… more
- Catalent Pharma Solutions (Philadelphia, PA)
- **Senior Engineer , Quality Operations** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... inspected at our facilities. Catalent Pharma Solutions in Philadelphia is hiring a Senior Engineer , Quality Operations. This position reports to the Quality … more
- Lilly (Concord, NC)
- …state-of-the-art manufacturing site and Quality System from the ground up. The HVAC Engineer is the site Subject Matter Expert (SME) for site HVAC (GMP and non ... 140 years. We make medicine with safety first and quality always while living our company values of Integrity,...within the facilities. During the project phase, the HVAC Engineer will be a key player in the cross… more
- Kelly Services (Parsippany, NJ)
- Kelly(R) Engineering is seeking a Quality Engineer (Equipment Deviation Investigation) for an excellent 8 month project with a growing pharmaceutical company in ... compliance with regulatory standards, and contributing to the continuous improvement of quality systems. Quality Engineer Responsibilities: + Conduct… more
- Lilly (Indianapolis, IN)
- …for clinical trial medicines, while also reducing costs and environmental impact. The HVAC Engineer is the site Subject Matter Expert (SME) for site HVAC (GMP and ... within the facilities. During the project phase, the HVAC Engineer will be a key player in the cross...+ Support internal and external inspections and investigations (including Quality and HSE) + Maintain efficient communications with appropriate… more
- Integra LifeSciences (Boston, MA)
- …treatment pathways to advance patient outcomes and set new standards of care. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for ... and development of new and improved products. The (DRA) Engineer II will interact with external design and development...* Support implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Quality Assurance Operations Engineer DSM (Night) is responsible to help drive the Quality oversight for the direction of all Drug ... Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM… more
- Edwards Lifesciences (Irvine, CA)
- …lives. Join us and be part of our inspiring journey. The Senior Principal Quality Engineer will apply knowledge of quality engineering principles and ... + Initiate and lead in the investigation of highly complex product quality and compliance issues (eg, PRAs, CAPA, non-conformances, audit observations) for all… more
- Novo Nordisk (Bloomington, IN)
- …use Excel, Word, and other office systems + Ability to learn and use quality management software such as TrackWise (R), ComplianceWire(R). and Maximo + Ability to ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...Novo Nordisk and help us make what matters. A Quality Engineering (QE) representative's primary duty is to review… more
- Applied Materials (Gloucester, MA)
- …to develop KPIs and metrics/measurement standards + Coorindate issue resolution using quality tools ( Trackwise , Advanced Problem Solving (APS), and statistical ... Applied. **Key Responsibilities** + Demonstrates intermediate knowledge and skills within Quality tools and methods and Training for FSO.Provide & participate… more
- Novo Nordisk (Bloomington, IN)
- …use Excel, Word, and other office systems + Ability to learn and use quality management software such as TrackWise (R), ComplianceWire(R) and Maximo + Ability to ... to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana… more
- Novo Nordisk (Bloomington, IN)
- …to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana ... us make what matters. As an Aseptic Manufacturing Process Engineer at Novo Nordisk, you will play a pivotal...you will play a pivotal role in ensuring the quality and efficiency of our aseptic manufacturing processes. You… more
- Novo Nordisk (Bloomington, IN)
- …to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana ... Nordisk and help us make what matters. As a Senior Aseptic Manufacturing Process Engineer at Novo Nordisk, you will leverage your extensive experience to lead the… more
- Lilly (Lebanon, IN)
- …a successful startup into GMP manufacturing operations. **Job Description:** The HVAC Engineer is responsible for overseeing the facilities at the Lebanon Plant 1 ... and systems are compliant and fit for use when needed. The HVAC Engineer will be responsible for the design, installation, maintenance, and repair of heating,… more
- Fujifilm (Holly Springs, NC)
- …Overview** The QA Engineer , DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project ... phase through to operational readiness. The QA Engineer , DSM is responsible for quality assurance...* Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise , MasterControl and/or Kneat validation software * Experience with… more