- Windstream Communications (Boston, MA)
- Quality Assurance Specialist Arkansas, USA * Georgia, USA * Iowa, USA * North Carolina, USA * Ohio, USA * South Carolina, USA * United StatesReq #1479 Tuesday, ... Role:** We are seeking a dedicated **Internal and Vendor Quality Assurance Specialist ** to oversee Kinetic's internal...methodologies and tools, such as TQM, Six Sigma, or ISO standards. + Excellent analytical skills and the ability… more
- Cambridge Isotope Laboratories, Inc. (Tewksbury, MA)
- Cambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of ... Review Reports, as needed + Contributor to various QA Quality Program functions when needed (eg Deviation, CAPA, Supplier... Assurance and knowledge and/or experience in ICH Q7, ISO 13485, is preferred + Excellent interpersonal, verbal and… more
- Integra LifeSciences (Boston, MA)
- …with Integra's internal operational laboratories to implement programs to improve their quality , reliability, and throughput. The Sr. Lab Specialist will be ... responsible for implementing continuous improvement programs, identifying and tracking quality and operational key performance indicators, implementing compliance programs,… more
- Philips (Cambridge, MA)
- The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market ... as CE Marking and product registrations, clinical evaluations in accordance with EU MDR, ISO 13485, and ISO 14155, China NMPA, Canada, Japan JPAL, compliance… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …program. Our Regulatory program is designed to meet the FDA's Quality System Regulation (QSR/Good Manufacturing Practices (GMP) and globally harmonized standard ... ISO 13485. Based on the information received, determine if...be interdepartmental interactions surrounding Post Market Surveillance activity involving Quality Assurance Engineering, Compliance, Technical Support, Service, and Regulatory… more
- Teleflex (Chelmsford, MA)
- …make a difference in patients' lives. **Position Summary** The Document Control & Records Specialist will support the Quality Team and will be responsible for ... Documentation Control and Records Specialist **Date:** Jul 17, 2024 **Location:** Chelmsford, MA,...work in a fast-paced dynamic environment. * Knowledge of Quality Management Systems under ISO 13485:2016 *… more
- Actalent (Bedford, MA)
- … Assurance/ Quality Compliance role. + Knowledge of GMP, FDA, ISO requirements. + Requires computer competence, including experience with database and Microsoft ... needed. + Review and approve incoming materials for release. + Provide quality assurance support of investigations including: nonconformance and root cause analysis.… more
- Fresenius Medical Center (Lexington, MA)
- PURPOSE AND SCOPE: The Senior Quality Specialist plays a pivotal role in maintaining and enhancing the quality management system (QMS) within the IT ... systems in IT. + Gained knowledge in GxP compliant documentation and quality management systems ( ISO 9001, GMP, ISO 13485) as well as documenting… more
- Stellant Systems (Topsfield, MA)
- **Overview** **Job Title:** Sr Quality Manager **Internal Job Title:** Senior Manager, Quality **Location:** Topsfield, MA **Salary:** $100,000-$120,000/yr ... detect, protect, and connect. **Responsibilities** Stellant Systems is seeking a talented **Sr Quality Manager** at our Topsfield, MA location to direct quality … more
- Black & Veatch (Burlington, MA)
- …for safety and regulatory standards (IEEE, IEC, NEC, NESC, NERC, ISO /RTO) to effectively define project requirements, review project deliverables (physical, P&C, ... Black and Veatch policies and procedures relative to assigned tasks Quality /Continuous Improvement: + Consistently and independently applies knowledge and complies… more
- Orchard Therapeutics (Boston, MA)
- …clinical team to provide key expertise in study specific, potentially specialist , bioassay set-up and implementation. Key elements and responsibilities . Serve ... as part of laboratory routine work o laboratory compliance/accreditation requirements (eg CLIA, ISO 15189) o global (US, EU, UK) LDT/IVD development o assay transfer… more
- ConvaTec (Lexington, MA)
- …across Convatec's Business Units. Reporting to the Clinical Study Management Specialist , this role will ensure clinical study execution is timely, cost-effective ... and in accordance with Convatec's policies and procedures, ISO , FDA and local regulations. **Key Responsibilities:** + Proactively...of processes and SOPs, with input on discussions around quality by design and operational delivery. + May be… more
- BD (Becton, Dickinson and Company) (Woburn, MA)
- …of all phases of work for Contractor: JLL + Supervise 2 Facilities Technician/ Specialist and 1 EHS Site Lead + Provide monthly look-ahead of planned maintenance ... improvement mentality, by recommending and implementing improvements in Safety, Quality , Cost, Inventory, Delivery + Work with team members...device manufacturing as it relates to FDA, GMP's and ISO + Ability to communicate well, both orally and… more
- CDM Smith (Boston, MA)
- …and/or US Society on Dams (USSD) - -\tServe as a technical specialist in the application of advanced geotechnical engineering theories, concepts, principles, and ... research and development projects - Embrace continuous improvement, drive a culture of quality , and meet commitments for sustained success - Work with clients in the… more