- Cipla (Central Islip, NY)
- Job Title QMS Lead - Investigations ...root cause analysis and corrective actions. Work closely with QA , AQA, operations, quality control, and other ... track competency. Utilize QMS software like TrackWise and SAP to manage quality processes. Ensure proper issuance, retrieval, and tracking of QMS documents… more
- Formation Bio (New York, NY)
- …efficiently.About the PositionWe are seeking a highly accomplished, strategic Vice President of Quality Assurance . In this pivotal role, you will have the ... the strategic development and operational management of Formation Bio's quality assurance program to support the growing...(SOPs) pertaining to GXP CSV and PV activities. Leading quality investigations and approving plans to address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …checks, and the proper escalation of critical issues.Partner with QMS QA to ensure consistent implementation of applicable Quality Standards in Medical ... GxP Quality representatives, and act as the Quality Assurance point person for all GxP...with other GxP QA functions (eg, GMP/IMP QA , Audit and Compliance, QMS QA… more
- Integra LifeSciences (Mansfield, MA)
- …non-conformity relating to product, process, or system. + Provides experienced quality assurance support to manufacturing, product development teams, ... of care. The **CAPA Specialist** is responsible for supporting the site Quality Management System ( QMS ) Corrective and Preventive Action (CAPA) program.… more
- Caris Life Sciences (Irving, TX)
- …Caris is where your impact begins.** **Position Summary** Senior Software Design Quality Assurance Engineer thinks "outside the box" in the implementation ... development project teams as a Computer Systems Validation (CSV) and Computer Software Assurance (CSA) quality subject matter expert and to ensue organizational… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …and combination products (FDA/ISO). + Lead Management Review meeting ensuring the Quality Management Systems ( QMS ) is suitable and effective. + Review and ... EU MDR (2017/745), CMDR (SOR/98-282). + Demonstrated ability to lead QA medical device and combination products...detail. + Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.… more
- Salamander Solutions (Houston, TX)
- …employees on QMS procedures and quality standards. Support QMS initiatives and investigations across departments. Oversee document control to ensure ... quality management, and a strong technical foundation in manufacturing and quality assurance . This position requires on-site presence. Essential Job Duties… more
- Integra LifeSciences (Mansfield, MA)
- …to the CAPA, NC and Quality Planning processes, and providing experienced quality assurance support to manufacturing and product development teams. This role ... non-conformity relating to product, process, or system. + Provides experienced quality assurance support to manufacturing, product development teams,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …science degree Knowledge and Skill: 15-25 years in Pharmaceutical Industry - Investigations , Sterile Manufacturing Quality Assurance , Validation and ... QA Director - Site Investigations & Quality systems Department: ...atypical product quality trends while review of investigations . Lead and develop quality … more
- Guidehouse (St. Louis, MO)
- …Required** **:** Ability to Obtain Public Trust We are currently searching for a Quality Assurance Specialist to provide support to the US Food & Drug ... update management on the status and effectiveness of the QMS . + Perform and lead software validation....of process improvement tools utilized. + Act as a Quality Assurance subject matter expert for technical… more
- Nitto Denko Corp. (Cincinnati, OH)
- …and supporting regulatory inspections and client audits. Key Job Responsibilities: + Lead the Quality Assurance function across the manufacturing ... with clients on QA -related matters, including product quality , audits, quality agreements, and investigations...strong relationships with client quality counterparts. + Lead , mentor, and develop the QA team… more
- Bristol Myers Squibb (Devens, MA)
- …there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration ... Control laboratories, and Warehouse Operations. The **Senior Specialist, Quality Assurance Shop Floor, Cell Therapy** position... Control and other supporting functions. The Senior Specialist, QA Shop Floor, is accountable to own quality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Director Quality Assurance - Distribution, US market, a member of the Global ... investigations into suspect product, as required. + Manage QMS records such as deviations (internal & external), CAPAs...degree or equivalent. + Deep knowledge and experience in quality assurance in a highly regulated manufacturing… more
- Noblis (San Diego, CA)
- Responsibilities **Electronic Engineering/ Quality Assurance ** Noblis MSD is seeking candidates for Electronic Engineering/ Quality Assurance to support ... the NIEF. This includes but not limited to: the quality assurance and the quality ...inspections. + Maintain compliance with standards of the NIEF quality management system ( QMS ) for ISO 9001:2015… more
- Bausch + Lomb (Tampa, FL)
- …Operating Procedures (SOPs), as deemed required. Lead and participate in investigations stemming from QMS systems **Audits & Inspections** Coordinate and ... initiatives. Responsible for various Quality System process improvements and Quality Assurance /System projects, which will require cross-functional work with… more
- Hologic (Newark, DE)
- …compliance. + Proven ability to lead moderate to complex quality projects, including risk management, defect investigations , and corrective actions ... Sr. Quality Assurance Engineer Newark, DE, United...distribution. In this role, you'll collaborate with cross-functional teams, lead quality initiatives, and drive continuous improvement… more
- V2X (Milton, FL)
- **Description** The QA Lead Auditor will oversee and lead the V2X Internal Audit and Corrective Action prosses to validate compliance to the PWS and AS9110 ... in support of the AHTS flight training program. The QA Lead Auditor duties may also include...responsible for the training of personnel assigned to the Quality Assurance Department as directed by the… more
- Bilfinger Industrial Services Inc. (Ithaca, NE)
- …point for addressing HSSE issues raised internally and externally. + Other duties as assigned. Quality Assurance : + Lead the organization in Quality ... recommendations to management in the review and implementation of Quality Assurance programs. Serve as an advocate...of manufacturing processes, practices and procedures. + Understanding of Quality Management Systems ( QMS ). + Experience in… more
- Curtiss-Wright Corporation (Santa Clarita, CA)
- Senior Quality Engineer- Defense-Onsite Position We have a rewarding opportunity for a **_Senior Quality Engineer_** based at our Curtiss-Wright Defense ... Solutions **_Santa Clarita, CA_** site. As our Senior Quality Engineer, you will be responsible for leading the Quality Engineering team that supports the… more
- Insight Global (South San Francisco, CA)
- …Biomedical Engineering, Biotechnology, or related technical field * 5+ years of hands-on quality assurance experience in the medical device or IVD industry * ... team, leading the development and implementation of a Quality Management System ( QMS ) from the ground...with international teams, especially in France * Ability to lead CAPA investigations and ensure timely resolution… more
